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    Clinical Trial Results:
    A Phase 1 Study to Evaluate the Bioavailability of Boosted Age-Appropriate Pediatric Elvitegravir (EVG) Tablet or Suspension Formulation Compared with Adult EVG 150 mg Tablets in Healthy Adult Volunteers

    Summary
    EudraCT number
    		 2015-000725-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-183-0149
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000968-PIP02-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was to evaluate the relative bioavailability and safety of 2 formulations (reduced-dose tablet and oral suspension) of elvitegravir (EVG) coadministered with ritonavir (RTV) in healthy adult participants.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    74
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 1 study site in the United States. The first participant was screened on 15 October 2012. The last study visit occurred on 08 December 2012.

    Pre-assignment
    Screening details
    		 129 participants were screened.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment B (test) = EVG 3 x 50 mg reduced-dose tablets + RTV 100 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir
    Investigational medicinal product code
    Other name
    Vitekta®, GS-9137
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EVG 150 mg adult tablet or 50 mg reduced-dose tablet administered orally in the morning immediately after a standard meal

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RTV 100 mg tablets administered orally in the morning immediately after a standard meal

    Arm title
    		 Cohort 2
    Arm description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir
    Investigational medicinal product code
    Other name
    Vitekta®, GS-9137
    Pharmaceutical forms
    Film-coated tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    EVG 150 mg adult tablet or 30 mL (5 mg/mL) oral suspension formulation administered orally in the morning immediately after a standard meal

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RTV 100 mg tablets administered orally in the morning immediately after a standard meal

    Arm title
    		 Cohort 3
    Arm description
    		 Treatment B (test) = EVG 3 × 50 mg reduced-dose tablets + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir
    Investigational medicinal product code
    Other name
    Vitekta®, GS-9137
    Pharmaceutical forms
    Film-coated tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg reduced-dose tablet or 30 mL (5 mg/mL) oral suspension formulation administered orally in the morning immediately after a standard meal

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RTV 100 mg tablets administered orally in the morning immediately after a standard meal

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3
    Started
    30
    26
    18
    Completed
    30
    26
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment B (test) = EVG 3 x 50 mg reduced-dose tablets + RTV 100 mg

    Reporting group title
    Cohort 2
    Reporting group description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg

    Reporting group title
    Cohort 3
    Reporting group description
    		 Treatment B (test) = EVG 3 × 50 mg reduced-dose tablets + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Total
    Number of subjects
    		 30 26 18 74
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28 ( 7.8 ) 27 ( 5.1 ) 27 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11 8 30
        Male
    		 19 15 10 44
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 1
        Asian
    		 2 0 0 2
        Black or African American
    		 18 16 10 44
        White
    		 10 10 7 27
    Ethnicity
    Units: Subjects
        Hispanic
    		 6 3 3 12
        Not Hispanic
    		 24 23 15 62

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment B (test) = EVG 3 x 50 mg reduced-dose tablets + RTV 100 mg

    Reporting group title
    Cohort 2
    Reporting group description
    		 Treatment A (reference) = EVG 150 mg tablet + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg

    Reporting group title
    Cohort 3
    Reporting group description
    		 Treatment B (test) = EVG 3 × 50 mg reduced-dose tablets + RTV 100 mg OR Treatment C (test) = EVG 30 mL (5 mg/mL) oral suspension formulation + RTV 100 mg

    Subject analysis set title
    Cohort 1, Treatment A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 1 who received a single dose of Treatment A (EVG 1 x 150 mg tablet) on Day 1 or 8

    Subject analysis set title
    Cohort 1, Treatment B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 1 who received a single dose of Treatment B (EVG 3 x 50 mg reduced-dose tablets) on Day 1 or 8

    Subject analysis set title
    Cohort 2, Treatment A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 2 who received a single dose of Treatment A (EVG 1 x 150 mg tablet) on Day 1 or 8

    Subject analysis set title
    Cohort 2, Treatment C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 2 who received a single dose of Treatment C (EVG 30 mL (5 mg/mL) oral suspension formulation) on Day 1 or 8

    Subject analysis set title
    Cohort 3, Treatment B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 3 who received daily doses of Treatment B (EVG 3 x 50 mg reduced-dose tablets) for 10 days

    Subject analysis set title
    Cohort 3, Treatment C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Cohort 3 who received daily doses of Treatment C (EVG 30 mL (5 mg/mL) oral suspension formulation) for 10 days

    Primary: Plasma Pharmacokinetics of EVG as measured by AUClast

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    End point title
    		 Plasma Pharmacokinetics of EVG as measured by AUClast
    End point description
    AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
    End point type
    Primary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng*h/mL
        geometric mean (confidence interval 95%)
    20054.3 (17806.8 to 22585.4)
    19974.5 (17459.7 to 22851.6)
    20352.9 (17390.8 to 23819.6)
    22601.4 (19302.7 to 26463.8)
    Statistical analysis title
    		 GLSM ratio - Treatments B vs Treatment A
    Statistical analysis description
    A parametric mixed effect analysis of variance (ANOVA) model was used to estimate the geometric least-squares mean (GLSM) ratio (Cohort 1: Treatment B/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 60; however, only 30 unique participants were analyzed, each reported for Treatment A and Treatment B.
    Comparison groups
    Cohort 1, Treatment A v Cohort 1, Treatment B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    99.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 93.17
         upper limit
    		 106.48
    Notes
    [1] - Intergroup comparison
    Statistical analysis title
    		 GLSM ratio - Treatment C vs Treatment A
    Statistical analysis description
    A parametric mixed effect ANOVA model was used to estimate the GLSM ratio (Cohort 2: Treatment C/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 52; however, only 26 unique participants were analyzed, each reported for Treatment A and C.
    Comparison groups
    Cohort 2, Treatment A v Cohort 2, Treatment C
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    111.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 102.76
         upper limit
    		 120
    Notes
    [2] - Intergroup comparison

    Primary: Plasma Pharmacokinetics of EVG as measured by AUCinf

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    End point title
    		 Plasma Pharmacokinetics of EVG as measured by AUCinf
    End point description
    AUCinf is defined as the concentration of drug extrapolated to infinite time.
    End point type
    Primary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng*h/mL
        geometric mean (confidence interval 95%)
    20959.5 (18484.5 to 23765.7)
    20973.5 (18365.9 to 23951.3)
    21374.2 (18351.4 to 24895)
    23370.8 (19994.3 to 27317.4)
    Statistical analysis title
    		 GLSM ratio - Treatment B vs Treatment A
    Statistical analysis description
    A parametric mixed effect ANOVA model was used to estimate the GLSM ratio (Cohort 1: Treatment B/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 60; however, only 30 unique participants were analyzed, each reported for Treatment A and Treatment B.
    Comparison groups
    Cohort 1, Treatment A v Cohort 1, Treatment B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    100.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 93.77
         upper limit
    		 106.78
    Notes
    [3] - Intergroup comparison
    Statistical analysis title
    		 GLSM ratio - Treatment C vs Treatment A
    Statistical analysis description
    A parametric mixed effect ANOVA model was used to estimate the GLSM ratio (Cohort 2: Treatment C/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 52; however, only 26 unique participants were analyzed, each reported for Treatment A and Treatment C.
    Comparison groups
    Cohort 2, Treatment A v Cohort 2, Treatment C
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    109.34
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 101.57
         upper limit
    		 117.71
    Notes
    [4] - Intergroup comparison

    Primary: Plasma Pharmacokinetics of EVG as measured by Cmax

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    End point title
    		 Plasma Pharmacokinetics of EVG as measured by Cmax
    End point description
    Cmax is defined as the maximum observed concentration of drug in plasma.
    End point type
    Primary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1572.9 (1406.7 to 1758.8)
    1573.2 (1396.4 to 1772.4)
    1543.9 (1326.4 to 1797)
    1665.7 (1413.5 to 1963)
    Statistical analysis title
    		 GLSM ratio - Treatment B vs Treatment A
    Statistical analysis description
    A parametric mixed effect ANOVA model was used to estimate the GLSM ratio (Cohort 1: Treatment B/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 60; however, only 30 unique participants were analyzed, each reported for Treatment A and Treatment B.
    Comparison groups
    Cohort 1, Treatment A v Cohort 1, Treatment B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    100.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 93.1
         upper limit
    		 107.45
    Notes
    [5] - Intergroup comparison
    Statistical analysis title
    		 GLSM ratio - Treatment C vs Treatment A
    Statistical analysis description
    A parametric mixed effect ANOVA model was used to estimate the GLSM ratio (Cohort 2: Treatment C/Treatment A) of the PK parameter and the corresponding 90% CI. Equivalence was concluded if the 90% CIs fell within the prespecified boundaries of 80% to 125%. "Subjects in this analysis" states 52; however, only 26 unique participants were analyzed, each reported for Treatment A and Treatment C.
    Comparison groups
    Cohort 2, Treatment A v Cohort 2, Treatment C
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Geometric least-squares mean ratio
    Point estimate
    107.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 98.67
         upper limit
    		 117.98
    Notes
    [6] - Intergroup comparison

    Secondary: Plasma Pharmacokinetics of RTV as measured by AUClast

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    End point title
    		 Plasma Pharmacokinetics of RTV as measured by AUClast
    End point description
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    4262.4 ( 2575.91 )
    4604.9 ( 2920.89 )
    4712.3 ( 2445.12 )
    4957.7 ( 2575.81 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics of RTV as measured by AUCinf

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    End point title
    		 Plasma Pharmacokinetics of RTV as measured by AUCinf
    End point description
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    4354.6 ( 2613.95 )
    4708.5 ( 2962.72 )
    4830.7 ( 2444.51 )
    5084.5 ( 2561.81 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics of RTV as measured by Cmax

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    End point title
    		 Plasma Pharmacokinetics of RTV as measured by Cmax
    End point description
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 36, and 48 hours postdose on Days 1 and 8
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C
    Number of subjects analysed
    30
    30
    26
    26
    Units: ng/mL
        arithmetic mean (standard deviation)
    645.1 ( 343.33 )
    713.2 ( 461.12 )
    743.5 ( 408.06 )
    796.2 ( 441.91 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics of EVG and RTV as measured by AUCtau

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    End point title
    		 Plasma Pharmacokinetics of EVG and RTV as measured by AUCtau
    End point description
    AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours postdose on Day 10
    End point values
    		 Cohort 3, Treatment B Cohort 3, Treatment C
    Number of subjects analysed
    9
    9
    Units: ng*h/mL
    arithmetic mean (standard deviation)
        EVG
    24126.8 ( 3728.29 )
    20635 ( 4919.31 )
        RTV
    6626 ( 2631.87 )
    6476.5 ( 3303.62 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics of EVG and RTV as measured by Ctau

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    End point title
    		 Plasma Pharmacokinetics of EVG and RTV as measured by Ctau
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval.
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours postdose on Day 10
    End point values
    		 Cohort 3, Treatment B Cohort 3, Treatment C
    Number of subjects analysed
    9
    9
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    411.3 ( 74.93 )
    376.9 ( 115.08 )
        RTV
    36.2 ( 22.62 )
    35.6 ( 16.79 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics of EVG and RTV as measured by Cmax

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    End point title
    		 Plasma Pharmacokinetics of EVG and RTV as measured by Cmax
    End point description
    End point type
    Secondary
    End point timeframe
    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours postdose on Day 10
    End point values
    		 Cohort 3, Treatment B Cohort 3, Treatment C
    Number of subjects analysed
    9
    9
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    2471.3 ( 555.92 )
    1939.9 ( 572.53 )
        RTV
    1162.8 ( 496.29 )
    1072.6 ( 809.78 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 15 days plus 30 days for Cohorts 1 and 2; up to 17 days plus 30 days for Cohort 3
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Treatment A in Cohorts 1 and 2
    Reporting group description
    		 Participants in Cohorts 1 and 2 who received Treatment A (EVG 1 x 150 mg tablet) were analyzed.

    Reporting group title
    Treatment B in Cohort 1
    Reporting group description
    		 Participants in Cohort 1 who received Treatment B (EVG 3 x 50 mg reduced-dose tablets) were analyzed.

    Reporting group title
    Treatment C in Cohort 2
    Reporting group description
    		 Participants in Cohort 2 who received Treatment C (EVG 30 mL (5 mg/mL) oral suspension formulation) were analyzed.

    Reporting group title
    Treatment B in Cohort 3
    Reporting group description
    		 Participants in Cohort 3 who received Treatment B (EVG 3 x 50 mg reduced-dose tablets) were analyzed.

    Reporting group title
    Treatment C in Cohort 3
    Reporting group description
    		 Participants in Cohort 3 who received Treatment C (EVG 30 mL (5 mg/mL) oral suspension formulation) were analyzed.

    Serious adverse events
    		 Treatment A in Cohorts 1 and 2 Treatment B in Cohort 1 Treatment C in Cohort 2 Treatment B in Cohort 3 Treatment C in Cohort 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment A in Cohorts 1 and 2 Treatment B in Cohort 1 Treatment C in Cohort 2 Treatment B in Cohort 3 Treatment C in Cohort 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 30 (6.67%)
    1 / 26 (3.85%)
    3 / 9 (33.33%)
    4 / 9 (44.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 30 (6.67%)
    1 / 26 (3.85%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
         occurrences all number
    1
    2
    1
    2
    1
    Dizziness
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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