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Clinical Trial Results:
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post-Operative Nausea and Vomiting

Summary
EudraCT number	2011-006006-27
Trial protocol	HU ES CZ IT Outside EU/EEA
Global end of trial date	26 Sep 2016

Results information
Results version number	v2(current)
This version publication date	02 Dec 2017
First version publication date	08 Apr 2017
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

0869-219

ISRCTN number

US NCT number

NCT01732458

WHO universal trial number (UTN)

Sponsor organisation name

Merck Sharp & Dohme Corp.

Sponsor organisation address

2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033

Public contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

Scientific contact

Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

26 Sep 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

26 Sep 2016

Global end of trial reached?

Yes

Global end of trial date

26 Sep 2016

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to evaluate the pharmacokinetics (PK), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric participants. Post-operative aprepitant plasma concentrations were evaluated with a non-compartmental analysis (NCA) at each dose and for each age cohort. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Full PK profiles analyzed using population PK modeling and simulation were described in a separate report.

Protection of trial subjects

This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Feb 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 7

Country: Number of subjects enrolled

Canada: 1

Country: Number of subjects enrolled

Chile: 35

Country: Number of subjects enrolled

Czech Republic: 20

Country: Number of subjects enrolled

Guatemala: 19

Country: Number of subjects enrolled

Hungary: 52

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Mexico: 3

Country: Number of subjects enrolled

Russian Federation: 4

Country: Number of subjects enrolled

South Africa: 22

Country: Number of subjects enrolled

Spain: 12

Country: Number of subjects enrolled

Turkey: 31

Country: Number of subjects enrolled

Ukraine: 3

Country: Number of subjects enrolled

United States: 13

Worldwide total number of subjects

228

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

116

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses (data reported separately in a narrative). Of remaining 228 randomized participants, 8 did not receive treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

This study conducted as a partially blinded study. PK samples were not collected from participants in the control group. To maintain a partial blind, ~3 participants randomly selected from each age group in each of the aprepitant treatment arms did not have PK sampling.

Are arms mutually exclusive

Yes

Aprepitant Dose 1: Equivalent to 125 mg in Adults

Arm description

Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.

Arm type

Experimental

Investigational medicinal product name

Aprepitant

Investigational medicinal product code

Other name

Emend, MK-0869

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.

Investigational medicinal product name

Placebo to Ondansetron

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

Aprepitant Dose 2: Equivalent to 40 mg in Adults

Arm description

Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.

Arm type

Experimental

Investigational medicinal product name

Aprepitant

Investigational medicinal product code

Other name

Emend, MK-0869

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Placebo to Ondansetron

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

Aprepitant Dose 3: Equivalent to 10 mg in Adults

Arm description

Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.

Arm type

Experimental

Investigational medicinal product name

Aprepitant

Investigational medicinal product code

Other name

Emend, MK-0869

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Placebo to Ondansetron

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

Ondansetron

Arm description

Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Arm type

Active comparator

Investigational medicinal product name

Placebo to Aprepitant

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Matching placebo to aprepritant was administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Investigational medicinal product name

Ondansetron

Investigational medicinal product code

Other name

Zofran

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Administered IV at a dose of 4 mg for participants >40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants <1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.

Number of subjects in period 1	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Started	60	58	58	52
Treated	57	55	56	52
Completed	57	53	55	50
Not completed	3	5	3	2
Physician decision	1	2	2	-
Screen Failure	-	1	-	-
Non-Compliance With Study Drug	-	-	1	-
Lost to follow-up	-	2	-	-
Protocol deviation	2	-	-	2

Baseline characteristics

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Reporting group title

Aprepitant Dose 1: Equivalent to 125 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 2: Equivalent to 40 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 3: Equivalent to 10 mg in Adults

Reporting group description

Reporting group title

Ondansetron

Reporting group description

Reporting group values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron	Total
Number of subjects	60	58	58	52	228
Age Categorical
All Participants as Treated (N=220)
Units: Subjects
Birth to <2 years	14	12	13	11	50
2 years to <6 years	14	14	15	14	57
6 years to <12 years	13	15	14	13	55
12 years to 17 years	16	14	14	14	58
Not Reported	3	3	2	0	8
Age Continuous
All Randomized Participants (N=228)
Units: months
arithmetic mean (standard deviation)	90.7 ± 64.6	86.1 ± 64.0	84.4 ± 59.7	86.0 ± 65.0	-
Gender Categorical
All Randomized Participants (N=228)
Units: Subjects
Female	24	20	29	16	89
Male	36	38	29	36	139

End points

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Reporting group title

Aprepitant Dose 1: Equivalent to 125 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 2: Equivalent to 40 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 3: Equivalent to 10 mg in Adults

Reporting group description

Reporting group title

Ondansetron

Reporting group description

Subject analysis set title

Aprepitant 125 mg (Dose 1): 12 to 17 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 12 to 17 years old received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 125 mg (Dose 1): 6 to <12 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 6 to <12 years old received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 125 mg (Dose 1): 2 to <6 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 2 to <6 years old received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 125 mg (Dose 1): Birth to <2 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged birth to <2 years old received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 40 mg (Dose 2): 12 to 17 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 12 to 17 years old received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 40 mg (Dose 2): 6 to <12 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 6 to <12 years old received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 40 mg (Dose 2): 2 to <6 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 2 to <6 years old received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 40 mg (Dose 2): Birth to <2 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged birth to <2 years old received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 10 mg (Dose 3): 12 to 17 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 12 to 17 years old received a single dose of apprepitant that was equivalent to 10 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 10 mg (Dose 3): 6 to <12 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 6 to <12 years old received a single dose of apprepitant that was equivalent to 10 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 10 mg (Dose 3): 2 to <6 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged 2 to <6 years old received a single dose of apprepitant that was equivalent to 10 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Subject analysis set title

Aprepitant 10 mg (Dose 3): Birth to <2 Year Age Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pediatric participants aged birth to <2 years old received a single dose of apprepitant that was equivalent to 10 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.

Primary: Area under the concentration-time curve of aprepitant from time 0 to the last measurable concentration (AUC0-last) following administration of 125 mg dose equivalent in 12 to 17 year age group

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End point title

Area under the concentration-time curve of aprepitant from time 0 to the last measurable concentration (AUC0-last) following administration of 125 mg dose equivalent in 12 to 17 year age group ^[1]

End point description

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a non-compartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	7120 ± 33.0

No statistical analyses for this end point

Primary: Maximum concentration (Cmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

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End point title

Maximum concentration (Cmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group ^[2]

End point description

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	1340 ± 43.9

No statistical analyses for this end point

Primary: Time to maximum concentration (Tmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

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End point title

Time to maximum concentration (Tmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group ^[3]

End point description

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	4.86 ± 56.5

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

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End point title

AUC0-last of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group ^[4]

End point description

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	10300 ± 39.5

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

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End point title

Cmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group ^[5]

End point description

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: ng/mL
geometric mean (geometric coefficient of variation)	1870 ± 53.0

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

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End point title

Tmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group ^[6]

End point description

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: hr
geometric mean (geometric coefficient of variation)	6.82 ± 26.8

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

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End point title

AUC0-last of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group ^[7]

End point description

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	12000 ± 39.7

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

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End point title

Cmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group ^[8]

End point description

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	2260 ± 35.7

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

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End point title

Tmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group ^[9]

End point description

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	4.91 ± 51.9

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

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End point title

AUC0-last of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group ^[10]

End point description

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): Birth to <2 Year Age Group
Number of subjects analysed	8
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	6410 ± 67.8

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

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End point title

Cmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group ^[11]

End point description

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): Birth to <2 Year Age Group
Number of subjects analysed	9
Units: ng/mL
geometric mean (geometric coefficient of variation)	1280 ± 78.5

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

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End point title

Tmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group ^[12]

End point description

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 125 mg (Dose 1): Birth to <2 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	4.71 ± 51.3

No statistical analyses for this end point

Primary: AUC0-last following administration of 40 mg dose equivalent in 12 to 17 year age group

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End point title

AUC0-last following administration of 40 mg dose equivalent in 12 to 17 year age group ^[13]

End point description

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 12 to 17 Year Age Group
Number of subjects analysed	11
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	2570 ± 41.5

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

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End point title

Cmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group ^[14]

End point description

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 12 to 17 Year Age Group
Number of subjects analysed	11
Units: ng/mL
geometric mean (geometric coefficient of variation)	513 ± 41.6

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

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End point title

Tmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group ^[15]

End point description

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 12 to 17 Year Age Group
Number of subjects analysed	11
Units: hr
geometric mean (geometric coefficient of variation)	4.17 ± 69.4

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

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End point title

AUC0-last of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group ^[16]

End point description

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	4730 ± 60.7

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

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End point title

Cmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group ^[17]

End point description

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: ng/mL
geometric mean (geometric coefficient of variation)	930 ± 66.7

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

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End point title

Tmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group ^[18]

End point description

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 6 to <12 Year Age Group
Number of subjects analysed	11
Units: hr
geometric mean (geometric coefficient of variation)	4.22 ± 53.4

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

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End point title

AUC0-last of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group ^[19]

End point description

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 2 to <6 Year Age Group
Number of subjects analysed	9
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	6320 ± 78.1

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Top of page

End point title

Cmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group ^[20]

End point description

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 2 to <6 Year Age Group
Number of subjects analysed	9
Units: ng/mL
geometric mean (geometric coefficient of variation)	1290 ± 81.7

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

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End point title

Tmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group ^[21]

End point description

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): 2 to <6 Year Age Group
Number of subjects analysed	9
Units: hr
geometric mean (geometric coefficient of variation)	3.35 ± 43.0

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

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End point title

AUC0-last of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group ^[22]

End point description

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): Birth to <2 Year Age Group
Number of subjects analysed	6
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	7910 ± 153.2

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Top of page

End point title

Cmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group ^[23]

End point description

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): Birth to <2 Year Age Group
Number of subjects analysed	6
Units: ng/mL
geometric mean (geometric coefficient of variation)	1570 ± 146.3

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Top of page

End point title

Tmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group ^[24]

End point description

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 40 mg (Dose 2): Birth to <2 Year Age Group
Number of subjects analysed	7
Units: hr
geometric mean (geometric coefficient of variation)	4.94 ± 38.0

No statistical analyses for this end point

Primary: AUC0-last following administration of 10 mg dose equivalent in 12 to 17 year age group

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End point title

AUC0-last following administration of 10 mg dose equivalent in 12 to 17 year age group ^[25]

End point description

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	806 ± 51.9

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Top of page

End point title

Cmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group ^[26]

End point description

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	131 ± 50.8

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Top of page

End point title

Tmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group ^[27]

End point description

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 12 to 17 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	3.53 ± 54.1

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

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End point title

AUC0-last of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group ^[28]

End point description

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 6 to <12 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	1390 ± 77.0

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

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End point title

Cmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group ^[29]

End point description

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 6 to <12 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	289 ± 128.4

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

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End point title

Tmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group ^[30]

End point description

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 6 to <12 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	3.75 ± 57.9

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

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End point title

AUC0-last of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group ^[31]

End point description

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	1580 ± 45.2

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

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End point title

Cmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group ^[32]

End point description

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	300 ± 49.9

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

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End point title

Tmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group ^[33]

End point description

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): 2 to <6 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	3.36 ± 45.8

No statistical analyses for this end point

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

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End point title

AUC0-last of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group ^[34]

End point description

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): Birth to <2 Year Age Group
Number of subjects analysed	10
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	1800 ± 107.8

No statistical analyses for this end point

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

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End point title

Cmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group ^[35]

End point description

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): Birth to <2 Year Age Group
Number of subjects analysed	10
Units: ng/mL
geometric mean (geometric coefficient of variation)	336 ± 112.0

No statistical analyses for this end point

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

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End point title

Tmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group ^[36]

End point description

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant PK assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated with a NCA. The LOQ value for this analysis was 10 ng/mL. Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with evaluable plasma samples were analyzed.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this NCA PK endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant 10 mg (Dose 3): Birth to <2 Year Age Group
Number of subjects analysed	10
Units: hr
geometric mean (geometric coefficient of variation)	4.11 ± 48.2

No statistical analyses for this end point

Primary: Area under the concentration-time curve of aprepitant from time 0 to infinity (AUC0-inf) following administration of single dose

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End point title

Area under the concentration-time curve of aprepitant from time 0 to infinity (AUC0-inf) following administration of single dose ^[37]

End point description

Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested. Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to a limited PK sampling scheme (up to 8 hours post-dose), NCA analysis was not performed for this endpoint.

End point values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Number of subjects analysed	0 ^[38]	0 ^[39]	0 ^[40]	0 ^[41]
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)	±	±	±	±

Notes
[38] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[39] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[40] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[41] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.

No statistical analyses for this end point

Primary: Apparent total clearance (CL/F) of aprepitant from plasma following administration of single dose

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End point title

Apparent total clearance (CL/F) of aprepitant from plasma following administration of single dose ^[42]

End point description

Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested. Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to a limited PK sampling scheme (up to 8 hours post-dose), NCA analysis was not performed for this endpoint.

End point values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Number of subjects analysed	0 ^[43]	0 ^[44]	0 ^[45]	0 ^[46]
Units: L/h
geometric mean (geometric coefficient of variation)	±	±	±	±

Notes
[43] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[44] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[45] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[46] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.

No statistical analyses for this end point

Primary: Apparent terminal half-life (t ½) of aprepitant following administration of single dose

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End point title

Apparent terminal half-life (t ½) of aprepitant following administration of single dose ^[47]

End point description

Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested. Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.

End point type

Primary

End point timeframe

30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Notes
[47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to a limited PK sampling scheme (up to 8 hours post-dose), NCA analysis was not performed for this endpoint.

End point values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Number of subjects analysed	0 ^[48]	0 ^[49]	0 ^[50]	0 ^[51]
Units: hr
geometric mean (geometric coefficient of variation)	±	±	±	±

Notes
[48] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[49] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[50] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.
[51] - Due to a limited PK sampling scheme (up to 8 hours post-dose), PK parameter not derived using NCA.

No statistical analyses for this end point

Primary: Percentage of participants experiencing at least one adverse event (AE)

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End point title

Percentage of participants experiencing at least one adverse event (AE)

End point description

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally ssociated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Events related to the exploratory efficacy endpoint (e.g., vomiting and retching) were not defined as AEs during the period of efficacy data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group. All randomized participants who received at least one dose of study treatment were analyzed.

End point type

Primary

End point timeframe

From pre-operative phase up to Follow-up (Day 1 to Day 15)

End point values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Number of subjects analysed	57	55	56	52
Units: percentage of participants
number (not applicable)	31.6	43.6	35.7	48.1

125 mg Aprepitant vs Odansetron: % Difference

Statistical analysis description

The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.

Comparison groups

Aprepitant Dose 1: Equivalent to 125 mg in Adults v Ondansetron

Number of subjects included in analysis

109

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in Percentage vs. Ondansetron

Point estimate

-16.5

Confidence interval

level

95%

sides

2-sided

lower limit

-34

upper limit

40 mg Aprepitant vs Odansetron: % Difference

Statistical analysis description

The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.

Comparison groups

Aprepitant Dose 2: Equivalent to 40 mg in Adults v Ondansetron

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in Percentage vs. Ondansetron

Point estimate

-4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-22.9

upper limit

14.3

10 mg Aprepitant vs Odansetron: % Difference

Statistical analysis description

The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.

Comparison groups

Aprepitant Dose 3: Equivalent to 10 mg in Adults v Ondansetron

Number of subjects included in analysis

108

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in Percentage vs. Ondansetron

Point estimate

-12.4

Confidence interval

level

95%

sides

2-sided

lower limit

-30.3

upper limit

6.3

Primary: Percentage of participants discontinuing study due to an AE

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End point title

Percentage of participants discontinuing study due to an AE ^[52]

End point description

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally ssociated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Events related to the exploratory efficacy endpoint (e.g., vomiting and retching) were not defined as AEs during the period of efficacy data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study treatment due to an AE was reported by dose group. All randomized participants who received at least one dose of study treatment were analyzed.

End point type

Primary

End point timeframe

From pre-operative phase up to hospital discharge (Day 1)

Notes
[52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics only were presented for this safety endpoint, and there were no between-group statistical comparisons performed.

End point values	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Number of subjects analysed	57	55	56	52
Units: percentage of participants
number (not applicable)	0.0	0.0	0.0	0.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From pre-operative phase up to Follow-up (Day 1 to Day 15)

Adverse event reporting additional description

All randomized participants who received at least one dose of study treatment were analyzed. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis (data reported as narrative).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Aprepitant Dose 1: Equivalent to 125 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 2: Equivalent to 40 mg in Adults

Reporting group description

Reporting group title

Aprepitant Dose 3: Equivalent to 10 mg in Adults

Reporting group description

Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.

Reporting group title

Ondansetron

Reporting group description

Serious adverse events	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 57 (0.00%)	6 / 55 (10.91%)	1 / 56 (1.79%)	2 / 52 (3.85%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Post procedural haemorrhage
subjects affected / exposed	0 / 57 (0.00%)	3 / 55 (5.45%)	0 / 56 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	0 / 57 (0.00%)	0 / 55 (0.00%)	0 / 56 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Thrombosis
subjects affected / exposed	0 / 57 (0.00%)	1 / 55 (1.82%)	0 / 56 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardio-respiratory arrest
subjects affected / exposed	0 / 57 (0.00%)	1 / 55 (1.82%)	0 / 56 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Male genital tract fistula
subjects affected / exposed	0 / 57 (0.00%)	0 / 55 (0.00%)	0 / 56 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
subjects affected / exposed	0 / 57 (0.00%)	1 / 55 (1.82%)	0 / 56 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Bladder perforation
subjects affected / exposed	0 / 57 (0.00%)	1 / 55 (1.82%)	0 / 56 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis
subjects affected / exposed	0 / 57 (0.00%)	0 / 55 (0.00%)	1 / 56 (1.79%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Aprepitant Dose 1: Equivalent to 125 mg in Adults	Aprepitant Dose 2: Equivalent to 40 mg in Adults	Aprepitant Dose 3: Equivalent to 10 mg in Adults	Ondansetron
Total subjects affected by non serious adverse events
subjects affected / exposed	11 / 57 (19.30%)	11 / 55 (20.00%)	12 / 56 (21.43%)	16 / 52 (30.77%)
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	0 / 57 (0.00%)	0 / 55 (0.00%)	1 / 56 (1.79%)	3 / 52 (5.77%)
occurrences all number	0	0	1	3
Procedural pain
subjects affected / exposed	4 / 57 (7.02%)	4 / 55 (7.27%)	3 / 56 (5.36%)	5 / 52 (9.62%)
occurrences all number	8	4	3	6
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	3 / 57 (5.26%)	1 / 55 (1.82%)	3 / 56 (5.36%)	0 / 52 (0.00%)
occurrences all number	5	1	5	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	3 / 57 (5.26%)	3 / 55 (5.45%)	4 / 56 (7.14%)	4 / 52 (7.69%)
occurrences all number	6	4	6	6
Vomiting
subjects affected / exposed	2 / 57 (3.51%)	3 / 55 (5.45%)	2 / 56 (3.57%)	4 / 52 (7.69%)
occurrences all number	3	3	3	6

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post-Operative Nausea and Vomiting

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Area under the concentration-time curve of aprepitant from time 0 to the last measurable concentration (AUC0-last) following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: Area under the concentration-time curve of aprepitant from time 0 to the last measurable concentration (AUC0-last) following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: Maximum concentration (Cmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: Maximum concentration (Cmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: Time to maximum concentration (Tmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: Time to maximum concentration (Tmax) of aprepitant following administration of 125 mg dose equivalent in 12 to 17 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: AUC0-last of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: Tmax of aprepitant following administration of 125 mg dose equivalent in birth to <2 year age group

Primary: AUC0-last following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: AUC0-last following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 12 to 17 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: AUC0-last of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: Tmax of aprepitant following administration of 40 mg dose equivalent in birth to <2 year age group

Primary: AUC0-last following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: AUC0-last following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 12 to 17 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 6 to <12 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: Tmax of aprepitant following administration of 10 mg dose equivalent in 2 to <6 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

Primary: AUC0-last of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

Primary: Cmax of aprepitant following administration of 10 mg dose equivalent in birth to <2 year age group

Clinical Trial Results:
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post-Operative Nausea and Vomiting