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    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
    EudraCT number
    		 2017-000953-38
    Trial protocol
    		 BG   GB   NO   Outside EU/EEA  
    Global end of trial date
    29 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2023
    First version publication date
    22 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-1986-014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03217565
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001379-PIP01-12
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Colombia: 19
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    47
    EEA total number of subjects
    18
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    17
    Newborns (0-27 days)
    16
    Infants and toddlers (28 days-23 months)
    14
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 30 centers in 5 countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 - 3 mg/kg

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    MK-1986
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 - 3 mg/kg

    Number of subjects in period 1
    		Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
    Started
    4
    6
    8
    4
    9
    4
    4
    4
    4
    Completed
    4
    6
    8
    4
    9
    4
    4
    4
    4

    Baseline characteristics

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    Baseline characteristics 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.

    Reporting group values
    		 Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Total
    Number of subjects
    		 4 6 8 4 9 4 4 4 4 47
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 9 4 0 0 4 17
        Newborns (0-27 days)
    		 0 0 8 4 0 0 0 4 0 16
        Infants and toddlers (28 days-23 months)
    		 4 6 0 0 0 0 4 0 0 14
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    		 51.3 ± 9.9 420.7 ± 167.1 8.3 ± 9.4 11.8 ± 11.3 9.9 ± 7.9 2.0 ± 1.2 289.0 ± 165.5 13.0 ± 11.7 6.5 ± 6.4 -
    Gender Categorical
    Units: Participants
        Female
    		 2 2 5 1 3 2 2 0 1 18
        Male
    		 2 4 3 3 6 2 2 4 3 29
    Race
    Units: Subjects
        American Indian or Alaskan Native
    		 0 0 0 1 0 0 0 0 0 1
        Black or African American
    		 1 0 0 0 0 0 0 0 0 1
        Multiple
    		 0 1 6 2 3 2 0 2 3 19
        White
    		 3 5 2 1 6 2 4 2 1 26
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 7 3 3 2 0 2 3 20
        Not Hispanic or Latino
    		 4 6 1 1 5 2 4 2 1 26
        Not reported
    		 0 0 0 0 1 0 0 0 0 1

    End points

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    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.

    Primary: 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

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    1
    0 [3]
    3
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    3
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    9999 ± 9999
    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

    Primary: Part A: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of tedizolid phosphate (prodrug) after single-dose IV administration

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    1
    0 [10]
    3
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    3
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    9999 ± 9999
    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

    Primary: Part A: Maximum concentration (Cmax) of tedizolid phosphate (prodrug) after single-dose IV administration

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    1
    0 [17]
    3
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    3
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    9999 ± 9999
    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

    Primary: Part A: Time to reach maximum concentration (Tmax) of tedizolid phosphate (prodrug) after single-dose IV administration

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    1
    0 [24]
    3
    0 [25]
    0 [26]
    0 [27]
    0 [28]
    3
    Units: hr
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    9999 ± 9999
    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

    Primary: Part A: AUC0-last of tedizolid phosphate (prodrug) after multiple-dose IV administration

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    End point title
    		 Part A: AUC0-last of tedizolid phosphate (prodrug) after multiple-dose IV administration [29] [30]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [31]
    0 [32]
    0 [33]
    2
    0 [34]
    0 [35]
    0 [36]
    3 [37]
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    9999 ± 9999
    ±
    ±
    ±
    9999 ± 9999
    Notes
    [31] - This endpoint is for Part A MD only.
    [32] - Did not meet the criteria for the per protocol population.
    [33] - This endpoint is for Part A MD only.
    [34] - Part B not analyzed, per protocol.
    [35] - Part B not analyzed, per protocol.
    [36] - Part B not analyzed, per protocol.
    [37] - This endpoint is for Part A MD only.
    No statistical analyses for this end point

    Primary: Part A: Apparent terminal half-life (t½) of tedizolid phosphate (prodrug) after single-dose IV administration

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    End point title
    		 Part A: Apparent terminal half-life (t½) of tedizolid phosphate (prodrug) after single-dose IV administration [38] [39]
    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
    [38] - 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.
    [39] - 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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    1
    0 [40]
    3
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    3
    Units: hr
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    9999 ± 9999
    Notes
    [40] - This endpoint is for Part A SD only.
    [41] - This endpoint is for Part A SD only.
    [42] - Part B not analyzed, per protocol.
    [43] - Part B not analyzed, per protocol.
    [44] - Part B not analyzed, per protocol.
    No statistical analyses for this end point

    Primary: Part A: AUC0-inf of tedizolid phosphate (prodrug) after multiple-dose IV administration

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [47]
    0 [48]
    0 [49]
    2
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    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

    Primary: Part A: Cmax of tedizolid phosphate (prodrug) after multiple-dose IV administration

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    End point title
    		 Part A: Cmax of tedizolid phosphate (prodrug) after multiple-dose IV administration [54] [55]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [56]
    0 [57]
    0 [58]
    2
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    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

    Primary: Part A: Tmax of tedizolid phosphate (prodrug) after multiple-dose IV administration

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    End point title
    		 Part A: Tmax of tedizolid phosphate (prodrug) after multiple-dose IV administration [63] [64]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [65]
    0 [66]
    0 [67]
    2
    0 [68]
    0 [69]
    0 [70]
    0 [71]
    Units: hr
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    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

    Primary: 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]

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    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] [72] [73]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    1
    1
    1
    0 [78]
    Units: hr*μg/mL
        number (not applicable)
    7.92
    9.25
    14.9
    Notes
    [74] - This endpoint is for Part B only.
    [75] - This endpoint is for Part B only.
    [76] - This endpoint is for Part B only.
    [77] - This endpoint is for Part B only.
    [78] - This endpoint is for Part B only.
    No statistical analyses for this end point

    Primary: Part A: t½ of tedizolid phosphate (prodrug) after multiple-dose IV administration

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    End point title
    		 Part A: t½ of tedizolid phosphate (prodrug) after multiple-dose IV administration [79] [80]
    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
    [79] - 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.
    [80] - 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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [81]
    0 [82]
    0 [83]
    2
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    Units: hr
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    9999 ± 9999
    ±
    ±
    ±
    ±
    Notes
    [81] - This endpoint is for Part A MD only.
    [82] - Did not meet the criteria for the per protocol population.
    [83] - This endpoint is for Part A MD only.
    [84] - Part B not analyzed, per protocol.
    [85] - Part B not analyzed, per protocol.
    [86] - Part B not analyzed, per protocol.
    [87] - This endpoint is for Part A MD only.
    No statistical analyses for this end point

    Primary: Part B: AUC0-inf of tedizolid after single-dose administration of tedizolid phosphate oral suspension

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [90]
    0 [91]
    0 [92]
    0 [93]
    1
    1
    1
    0 [94]
    Units: hr*μg/mL
        number (not applicable)
    8.36
    9.44
    22.1
    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

    Primary: Part B: Cmax of tedizolid after single-dose administration of tedizolid phosphate oral suspension

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [97]
    0 [98]
    0 [99]
    0 [100]
    1
    1
    1
    0 [101]
    Units: μg/mL
        number (not applicable)
    1.32
    0.899
    1.22
    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

    Primary: Part B: t½ of tedizolid after single-dose administration of tedizolid phosphate oral suspension

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    End point title
    		 Part B: t½ of tedizolid after single-dose administration of tedizolid phosphate oral suspension [102] [103]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [104]
    0 [105]
    0 [106]
    0 [107]
    1
    1
    1
    0 [108]
    Units: hr
        number (not applicable)
    5.73
    3.82
    13.4
    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

    Primary: Part B: Tmax of tedizolid after single-dose administration of tedizolid phosphate oral suspension

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    End point title
    		 Part B: Tmax of tedizolid after single-dose administration of tedizolid phosphate oral suspension [109] [110]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [111]
    0 [112]
    0 [113]
    0 [114]
    1
    1
    1
    0 [115]
    Units: hr
        number (not applicable)
    1
    3.03
    8
    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

    Primary: Part A: AUC0-24 of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [AUC0-last]

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    5
    0 [118]
    3
    0 [119]
    0 [120]
    0 [121]
    0 [122]
    10
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    8.23 ± 115.9
    ±
    15.6 ± 17.6
    ±
    ±
    ±
    ±
    13.6 ± 42.4
    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

    Primary: Part A: AUC0-inf of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    5
    0 [125]
    3
    0 [126]
    0 [127]
    0 [128]
    0 [129]
    10
    Units: hr*μg/mL
        geometric mean (geometric coefficient of variation)
    9.21 ± 128.2
    ±
    17.8 ± 20.9
    ±
    ±
    ±
    ±
    14.3 ± 40.4
    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

    Primary: Part A: Cmax of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    5
    0 [132]
    3
    0 [133]
    0 [134]
    0 [135]
    0 [136]
    10
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    0.962 ± 71.9
    ±
    1.35 ± 44.5
    ±
    ±
    ±
    ±
    2.19 ± 51.0
    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

    Primary: Part A: Tmax of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate

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    End point title
    		 Part A: Tmax of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [137] [138]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    5
    0 [139]
    3
    0 [140]
    0 [141]
    0 [142]
    0 [143]
    10
    Units: hr
        median (full range (min-max))
    1.41 (1.00 to 2.50)
    ( to )
    1.50 (1.08 to 6.53)
    ( to )
    ( to )
    ( to )
    ( to )
    1.33 (1.00 to 1.58)
    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

    Primary: Part A: t½ of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate

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    End point title
    		 Part A: t½ of tedizolid (active metabolite) after single-dose IV administration of tedizolid phosphate [144] [145]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    5
    0 [146]
    3
    0 [147]
    0 [148]
    0 [149]
    0 [150]
    10
    Units: hr
        geometric mean (geometric coefficient of variation)
    6.63 ± 38.0
    ±
    7.08 ± 41.2
    ±
    ±
    ±
    ±
    4.17 ± 47.7
    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

    Primary: Part A: AUC0-12 of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [AUC0-last]

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [153]
    1
    0 [154]
    1
    0 [155]
    0 [156]
    0 [157]
    0 [158]
    Units: hr*μg/mL
        number (not applicable)
    10.5
    7.48
    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

    Primary: Part A: Tmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate

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    End point title
    		 Part A: Tmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [159] [160]
    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
    [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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [161]
    1
    0 [162]
    1
    0 [163]
    0 [164]
    0 [165]
    0 [166]
    Units: hr
        number (not applicable)
    1.60
    1.08
    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

    Primary: Part A: Cmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate

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    End point title
    		 Part A: Cmax of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate [167] [168]
    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.
    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [169]
    1
    0 [170]
    1
    0 [171]
    0 [172]
    0 [173]
    0 [174]
    Units: μg/mL
        number (not applicable)
    1.82
    1.69
    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.
    No statistical analyses for this end point

    Primary: Part A: AUC0-inf of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate

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    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [177]
    0 [178]
    0 [179]
    0 [180]
    0 [181]
    0 [182]
    0 [183]
    0 [184]
    Units: hr*μg/mL
        number (not applicable)
    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.
    No statistical analyses for this end point

    Primary: Part A: t½ of tedizolid (active metabolite) after multiple-dose IV administration of tedizolid phosphate

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    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.
    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).
    End point values
    		 Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months
    Number of subjects analysed
    0 [187]
    0 [188]
    0 [189]
    0 [190]
    0 [191]
    0 [192]
    0 [193]
    0 [194]
    Units: hr
        number (not applicable)
    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.
    No statistical analyses for this end point

    Secondary: Number of participants with an Adverse Event (AE)

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    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
    End point values
    		 Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
    Number of subjects analysed
    4
    6
    8
    4
    9
    4
    4
    4
    4
    Units: Participants
    1
    1
    0
    0
    2
    2
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of participants that discontinued study treatment due to an AE

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    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.
    End point type
    Secondary
    End point timeframe
    Up to approximately 3 days
    End point values
    		 Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days
    Number of subjects analysed
    4
    6
    8
    4
    9
    4
    4
    4
    4
    Units: Participants
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 21 days
    Adverse event reporting additional description
    Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    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 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
    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 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.

    Serious adverse events
    		 Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Therapeutic product effect incomplete
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 Cohort 1:SD IV Tedizolid Phosphate 28days-<6months Group 1 Cohort 2: SD IV Tedizolid Phosphate 6-<24months Group 2 Cohort 1: SD IV Tedizolid Phosphate FT birth-28days Group 2 Cohort 2: MD IV Tedizolid Phosphate FT birth-28days Group 6: SD Oral Tedizolid Phosphate PT birth-<28days Group 3 Cohort 2: MD IV Tedizolid Phosphate PT birth-28days Group 4: SD Oral Tedizolid Phosphate 28days-<24months Group 5: SD Oral Tedizolid Phosphate FT birth-<28days Group 3 Cohort 1: SD IV Tedizolid Phosphate PT birth-28days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    Investigations
    Immature granulocyte count increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Jaundice neonatal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary dysplasia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Serratia sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.
    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.
    22 Jul 2021
    AM4: To clarify that participants can receive the oral suspension dose via feeding tube.
    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.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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