Clinical Trial Results:
A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
Summary
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EudraCT number |
2017-000953-38 |
Trial protocol |
BG GB NO Outside EU/EEA |
Global end of trial date |
29 Mar 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Oct 2023
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First version publication date |
22 Oct 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MK-1986-014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03217565 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme LLC
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Sponsor organisation address |
126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001379-PIP01-12 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Mar 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Mar 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Mar 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objectives of this study are to describe the single-dose (SD), and multiple dose (MD)
pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension
of tedizolid phosphate, when administered to pediatric participants, full-term (FT) neonates, and
preterm (PT) neonates. Part A consists of study arms: Group 1 Cohort 1, Group 1 Cohort 2,
Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2 and Part B consists of
Groups 4, 5 and 6.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Feb 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 13
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Country: Number of subjects enrolled |
Colombia: 19
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Country: Number of subjects enrolled |
Norway: 5
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Country: Number of subjects enrolled |
United Kingdom: 5
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Country: Number of subjects enrolled |
United States: 5
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Worldwide total number of subjects |
47
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
17
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Newborns (0-27 days) |
16
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Infants and toddlers (28 days-23 months) |
14
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was conducted at 30 centers in 5 countries. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants were enrolled and allocated to 1 of 9 groups/cohorts to receive either single IV infusion, multiple IV infusions (twice daily for 3 days) or single oral suspension dose of Tedizolid Phosphate (MK-1986). | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months | ||||||||||||||||||||||||||||||
Arm description |
Pediatric participants 28 days to <6 months of age received a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months | ||||||||||||||||||||||||||||||
Arm description |
Pediatric participants 6 months to <24 months of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days | ||||||||||||||||||||||||||||||
Arm description |
Full term (FT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days | ||||||||||||||||||||||||||||||
Arm description |
FT neonates from birth to 28 days of age received multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days | ||||||||||||||||||||||||||||||
Arm description |
Preterm (PT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days | ||||||||||||||||||||||||||||||
Arm description |
PT neonates from birth to 28 days of age received MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 4: SD Oral Tedizolid Phosphate 28days-<24months | ||||||||||||||||||||||||||||||
Arm description |
Pediatric participants 28 days to <24 months of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 5: SD Oral Tedizolid Phosphate FT birth-<28days | ||||||||||||||||||||||||||||||
Arm description |
FT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
2.5 - 3 mg/kg
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Arm title
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Group 6: SD Oral Tedizolid Phosphate PT birth-<28days | ||||||||||||||||||||||||||||||
Arm description |
PT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tedizolid Phosphate
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Investigational medicinal product code |
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Other name |
MK-1986
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
2.5 - 3 mg/kg
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Baseline characteristics reporting groups
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Reporting group title |
Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months
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Reporting group description |
Pediatric participants 28 days to <6 months of age received a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months
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Reporting group description |
Pediatric participants 6 months to <24 months of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days
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Reporting group description |
Full term (FT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days
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Reporting group description |
FT neonates from birth to 28 days of age received multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days
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Reporting group description |
Preterm (PT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days
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Reporting group description |
PT neonates from birth to 28 days of age received MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: SD Oral Tedizolid Phosphate 28days-<24months
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Reporting group description |
Pediatric participants 28 days to <24 months of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 5: SD Oral Tedizolid Phosphate FT birth-<28days
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
FT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
PT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months
|
||
Reporting group description |
Pediatric participants 28 days to <6 months of age received a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months
|
||
Reporting group description |
Pediatric participants 6 months to <24 months of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days
|
||
Reporting group description |
Full term (FT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days
|
||
Reporting group description |
FT neonates from birth to 28 days of age received multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||
Reporting group title |
Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days
|
||
Reporting group description |
Preterm (PT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days
|
||
Reporting group description |
PT neonates from birth to 28 days of age received MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||
Reporting group title |
Group 4: SD Oral Tedizolid Phosphate 28days-<24months
|
||
Reporting group description |
Pediatric participants 28 days to <24 months of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 5: SD Oral Tedizolid Phosphate FT birth-<28days
|
||
Reporting group description |
FT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Reporting group title |
Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
|
||
Reporting group description |
PT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||
Subject analysis set title |
Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Pediatric participants 28 days to <24 months of age received a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
|
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Area under the concentration-time curve from time 0 to time of last quantifiable drug concentration (AUC0-last) of tedizolid phosphate (prodrug) after single-dose IV administration [1] [2] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates AUC was not calculated due to plasma concentrations below level of quantification (BLOQ), based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [3] - This endpoint is for Part A SD only. [4] - This endpoint is for Part A SD only. [5] - Part B not analyzed, per protocol. [6] - Part B not analyzed, per protocol. [7] - Part B not analyzed, per protocol. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of tedizolid phosphate (prodrug) after single-dose IV administration [8] [9] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates AUC was not calculated due to plasma concentrations below level of quantification (BLOQ), based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [10] - This endpoint is for Part A SD only. [11] - This endpoint is for Part A SD only. [12] - Part B not analyzed, per protocol. [13] - Part B not analyzed, per protocol. [14] - Part B not analyzed, per protocol. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Maximum concentration (Cmax) of tedizolid phosphate (prodrug) after single-dose IV administration [15] [16] | ||||||||||||||||||||||||||||||||||||
End point description |
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates Cmax was not calculated due to plasma concentrations below level of quantification (BLOQ), based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [17] - This endpoint is for Part A SD only. [18] - This endpoint is for Part A SD only. [19] - Part B not analyzed, per protocol. [20] - Part B not analyzed, per protocol. [21] - Part B not analyzed, per protocol. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Time to reach maximum concentration (Tmax) of tedizolid phosphate (prodrug) after single-dose IV administration [22] [23] | ||||||||||||||||||||||||||||||||||||
End point description |
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates Tmax was not calculated due to plasma concentrations below level of quantification (BLOQ), based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [24] - This endpoint is for Part A SD only. [25] - This endpoint is for Part A SD only. [26] - Part B not analyzed, per protocol. [27] - Part B not analyzed, per protocol. [28] - Part B not analyzed, per protocol. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Apparent terminal half-life (t½) of tedizolid phosphate (prodrug) after single-dose IV administration [29] [30] | ||||||||||||||||||||||||||||||||||||
End point description |
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates t½ was not calculated due to plasma concentrations below level of quantification (BLOQ), based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, t½ for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [31] - This endpoint is for Part A SD only. [32] - This endpoint is for Part A SD only. [33] - Part B not analyzed, per protocol. [34] - Part B not analyzed, per protocol. [35] - Part B not analyzed, per protocol. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-last of tedizolid phosphate (prodrug) after multiple-dose IV administration [36] [37] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates AUC was not calculated due to plasma BLOQ, based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
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: No between-arm statistical comparisons were planned for this endpoint. [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [38] - This endpoint is for Part A MD only. [39] - Did not meet the criteria for the per protocol population. [40] - This endpoint is for Part A MD only. [41] - Part B not analyzed, per protocol. [42] - Part B not analyzed, per protocol. [43] - Part B not analyzed, per protocol. [44] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-inf of tedizolid phosphate (prodrug) after multiple-dose IV administration [45] [46] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates AUC was not calculated due to plasma BLOQ, based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-inf for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [45] - 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: No between-arm statistical comparisons were planned for this endpoint. [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [47] - This endpoint is for Part A MD only. [48] - Did not meet the criteria for the per protocol population. [49] - This endpoint is for Part A MD only. [50] - Part B not analyzed, per protocol. [51] - Part B not analyzed, per protocol. [52] - Part B not analyzed, per protocol. [53] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Tmax of tedizolid phosphate (prodrug) after multiple-dose IV administration [54] [55] | ||||||||||||||||||||||||||||||||||||
End point description |
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates Tmax was not calculated due to plasma BLOQ, based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. As specified in the protocol, Tmax for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [54] - 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: No between-arm statistical comparisons were planned for this endpoint. [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [56] - This endpoint is for Part A MD only. [57] - Did not meet the criteria for the per protocol population. [58] - This endpoint is for Part A MD only. [59] - Part B not analyzed, per protocol. [60] - Part B not analyzed, per protocol. [61] - Part B not analyzed, per protocol. [62] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Cmax of tedizolid phosphate (prodrug) after multiple-dose IV administration [63] [64] | ||||||||||||||||||||||||||||||||||||
End point description |
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates Cmax was not calculated due to plasma BLOQ, based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. As specified in the protocol, Cmax for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [63] - 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: No between-arm statistical comparisons were planned for this endpoint. [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [65] - This endpoint is for Part A MD only. [66] - Did not meet the criteria for the per protocol population. [67] - This endpoint is for Part A MD only. [68] - Part B not analyzed, per protocol. [69] - Part B not analyzed, per protocol. [70] - Part B not analyzed, per protocol. [71] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: t½ of tedizolid phosphate (prodrug) after multiple-dose IV administration [72] [73] | ||||||||||||||||||||||||||||||||||||
End point description |
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. ”9999” indicates t½ was not calculated due to plasma BLOQ, based on protocol. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. As specified in the protocol, t½ for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this endpoint and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [72] - 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: No between-arm statistical comparisons were planned for this endpoint. [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [74] - This endpoint is for Part A MD only. [75] - Did not meet the criteria for the per protocol population. [76] - This endpoint is for Part A MD only. [77] - Part B not analyzed, per protocol. [78] - Part B not analyzed, per protocol. [79] - Part B not analyzed, per protocol. [80] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: Area under the concentration-time curve from time 0 to 24 hours (AUC0-24) of tedizolid after single-dose administration of tedizolid phosphate oral suspension [AUC0-last] [81] [82] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-last of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 3, 5, 8, 12, and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [81] - 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: No between-arm statistical comparisons were planned for this endpoint. [82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [83] - This endpoint is for Part B only. [84] - This endpoint is for Part B only. [85] - This endpoint is for Part B only. [86] - This endpoint is for Part B only. [87] - This endpoint is for Part B only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: AUC0-inf of tedizolid after single-dose administration of tedizolid phosphate oral suspension [88] [89] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-inf of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-inf for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 3, 5, 8, 12, and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [88] - 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: No between-arm statistical comparisons were planned for this endpoint. [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [90] - This endpoint is for Part B only. [91] - This endpoint is for Part B only. [92] - This endpoint is for Part B only. [93] - This endpoint is for Part B only. [94] - This endpoint is for Part B only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: Cmax of tedizolid after single-dose administration of tedizolid phosphate oral suspension [95] [96] | ||||||||||||||||||||||||||||||||||||
End point description |
Cmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, Cmax for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 3, 5, 8, 12, and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [95] - 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: No between-arm statistical comparisons were planned for this endpoint. [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [97] - This endpoint is for Part B only. [98] - This endpoint is for Part B only. [99] - This endpoint is for Part B only. [100] - This endpoint is for Part B only. [101] - This endpoint is for Part B only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: Tmax of tedizolid after single-dose administration of tedizolid phosphate oral suspension [102] [103] | ||||||||||||||||||||||||||||||||||||
End point description |
Tmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, Tmax for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 3, 5, 8, 12, and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [102] - 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: No between-arm statistical comparisons were planned for this endpoint. [103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [104] - This endpoint is for Part B only. [105] - This endpoint is for Part B only. [106] - This endpoint is for Part B only. [107] - This endpoint is for Part B only. [108] - This endpoint is for Part B only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part B: t½ of tedizolid after single-dose administration of tedizolid phosphate oral suspension [109] [110] | ||||||||||||||||||||||||||||||||||||
End point description |
t½ of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, t½ for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 3, 5, 8, 12, and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [109] - 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: No between-arm statistical comparisons were planned for this endpoint. [110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [111] - This endpoint is for Part B only. [112] - This endpoint is for Part B only. [113] - This endpoint is for Part B only. [114] - This endpoint is for Part B only. [115] - This endpoint is for Part B only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-24 of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [AUC0-last] [116] [117] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-last of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-last for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [116] - 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: No between-arm statistical comparisons were planned for this endpoint. [117] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [118] - This endpoint is for Part A SD only. [119] - This endpoint is for Part A SD only. [120] - This endpoint is for Part A SD only. [121] - This endpoint is for Part A SD only. [122] - This endpoint is for Part A SD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-inf of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [123] [124] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-inf of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [123] - 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: No between-arm statistical comparisons were planned for this endpoint. [124] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [125] - This endpoint is for Part A SD only. [126] - This endpoint is for Part A SD only. [127] - This endpoint is for Part A SD only. [128] - This endpoint is for Part A SD only. [129] - This endpoint is for Part A SD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Cmax of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [130] [131] | ||||||||||||||||||||||||||||||||||||
End point description |
Cmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Cmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [130] - 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: No between-arm statistical comparisons were planned for this endpoint. [131] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [132] - This endpoint is for Part A SD only. [133] - This endpoint is for Part A SD only. [134] - This endpoint is for Part A SD only. [135] - This endpoint is for Part A SD only. [136] - This endpoint is for Part A SD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: t½ of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [137] [138] | ||||||||||||||||||||||||||||||||||||
End point description |
t½ of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, t½ for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [137] - 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: No between-arm statistical comparisons were planned for this endpoint. [138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [139] - This endpoint is for Part A SD only. [140] - This endpoint is for Part A SD only. [141] - This endpoint is for Part A SD only. [142] - This endpoint is for Part A SD only. [143] - This endpoint is for Part A SD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Tmax of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [144] [145] | ||||||||||||||||||||||||||||||||||||
End point description |
Tmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, according to the underlying scientific model and had data available for this endpoint. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Tmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [144] - 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: No between-arm statistical comparisons were planned for this endpoint. [145] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [146] - This endpoint is for Part A SD only. [147] - This endpoint is for Part A SD only. [148] - This endpoint is for Part A SD only. [149] - This endpoint is for Part A SD only. [150] - This endpoint is for Part A SD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-12 of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [AUC0-last] [151] [152] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-last of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [151] - 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: No between-arm statistical comparisons were planned for this endpoint. [152] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Notes [153] - This endpoint is for Part A MD only. [154] - This endpoint is for Part A MD only. [155] - This endpoint is for Part A MD only. [156] - This endpoint is for Part A MD only. [157] - This endpoint is for Part A MD only. [158] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: Cmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [159] [160] | ||||||||||||||||||||||||||||||||||||
End point description |
Cmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, Cmax for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
|
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End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
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Notes [159] - 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: No between-arm statistical comparisons were planned for this endpoint. [160] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
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Notes [161] - This endpoint is for Part A MD only. [162] - This endpoint is for Part A MD only. [163] - This endpoint is for Part A MD only. [164] - This endpoint is for Part A MD only. [165] - This endpoint is for Part A MD only. [166] - This endpoint is for Part A MD only. |
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
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End point title |
Part A: Tmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [167] [168] | ||||||||||||||||||||||||||||||||||||
End point description |
Tmax of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. Measure of dispersion couldn’t be estimated due to low number of participants analyzed. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, Tmax for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [167] - 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: No between-arm statistical comparisons were planned for this endpoint. [168] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
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|
|||||||||||||||||||||||||||||||||||||
Notes [169] - This endpoint is for Part A MD only. [170] - This endpoint is for Part A MD only. [171] - This endpoint is for Part A MD only. [172] - This endpoint is for Part A MD only. [173] - This endpoint is for Part A MD only. [174] - This endpoint is for Part A MD only. |
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: AUC0-inf of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [175] [176] | ||||||||||||||||||||||||||||||||||||
End point description |
AUC0-inf of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol to ensure that these data would likely exhibit treatment effects, based on the underlying scientific model and had data available. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, AUC0-inf of tedizolid metabolite could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in single dose (Part A Group 1[Cohorts 1 and 2],Group 2 Cohort 1, Group 3 Cohort 1; Part B[Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [175] - 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: No between-arm statistical comparisons were planned for this endpoint. [176] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
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|
|||||||||||||||||||||||||||||||||||||
Notes [177] - This endpoint is for Part A MD only. [178] - Could not be estimated per protocol-specified PK sampling scheme. [179] - This endpoint is for Part A MD only. [180] - Could not be estimated per protocol-specified PK sampling scheme. [181] - This endpoint is for Part A MD only. [182] - This endpoint is for Part A MD only. [183] - This endpoint is for Part A MD only. [184] - This endpoint is for Part A MD only. |
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Part A: t½ of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [185] [186] | ||||||||||||||||||||||||||||||||||||
End point description |
t½ of tedizolid metabolite was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, t½ could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, t½ for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
|
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End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
|
||||||||||||||||||||||||||||||||||||
Notes [185] - 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: No between-arm statistical comparisons were planned for this endpoint. [186] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). |
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|
|||||||||||||||||||||||||||||||||||||
Notes [187] - This endpoint is for Part A MD only. [188] - Could not be estimated per protocol-specified PK sampling scheme. [189] - This endpoint is for Part A MD only. [190] - Could not be estimated per protocol-specified PK sampling scheme. [191] - This endpoint is for Part A MD only. [192] - This endpoint is for Part A MD only. [193] - This endpoint is for Part A MD only. [194] - This endpoint is for Part A MD only. |
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Number of participants with an Adverse Event (AE) | ||||||||||||||||||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE was reported for each arm. All subjects who received at least one dose of the investigational drug were assessed.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Up to approximately 21 days
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Number of participants that discontinued study treatment due to an AE | ||||||||||||||||||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported for each arm. All subjects who received at least one dose of the investigational drug were assessed.
|
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End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Up to approximately 3 days
|
||||||||||||||||||||||||||||||
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No statistical analyses for this end point |
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Up to approximately 21 days
|
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Adverse event reporting additional description |
Safety: All participants who received at least one dose of the investigational drug.
All-cause mortality: All allocated participants
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months
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Reporting group description |
Pediatric participants 28 days to <6 months of age received a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Pediatric participants 6 months to <24 months of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Full term (FT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
FT neonates from birth to 28 days of age received multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
PT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
PT neonates from birth to 28 days of age received MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: SD Oral Tedizolid Phosphate 28days-<24months
|
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Reporting group description |
Pediatric participants 28 days to <24 months of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 5: SD Oral Tedizolid Phosphate FT birth-<28days
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Reporting group description |
FT neonates from birth to <28 days of age received an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days
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Reporting group description |
Preterm (PT) neonates from birth to 28 days of age received an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Oct 2018 |
AM1: To ensure an adequate distribution of age and weight among subjects aged 28 days to <24 months, particularly among subjects aged 28 days to <6 months. |
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31 Oct 2019 |
AM2: To update the dose levels following the first interim analysis and to convert the second IV cohort of each neonatal group to receive multiple (not single) doses. |
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22 Jul 2021 |
AM4: To clarify that participants can receive the oral suspension dose via feeding tube. |
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15 Feb 2023 |
AM5: To remove the dependency of enrollment of the second cohorts of Groups 2 and 3 on the availability of safety/tolerability data from Study MK-1986-018. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |