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    Clinical Trial Results:
    A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

    Summary
    EudraCT number
    		 2015-004595-29
    Trial protocol
    		 Outside EU/EEA   GB  
    Global end of trial date
    21 Dec 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Mar 2021
    First version publication date
    28 Jun 2019
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-1986-013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02750761
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Cubist Protocol Number: TR701-120
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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
    21 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate (MK-1986) and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single intravenous (IV) or oral suspension administration to hospitalized participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).
    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
    02 May 2016
    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
    Colombia: 1
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    32
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    32
    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
    		 -

    Pre-assignment
    Screening details
    		 Prior to enrollment, participants were receiving prophylaxis for or with a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years)
    Arm description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/kg administered by intravenous infusion

    Arm title
    		 Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years)
    Arm description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 mg/kg administered by intravenous infusion

    Arm title
    		 Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years)
    Arm description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    6 mg/kg administered by intravenous infusion

    Arm title
    		 Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Arm description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg administered by intravenous infusion

    Arm title
    		 Group 3: Tedizolid oral 4 mg/kg (6 to <12 years)
    Arm description
    		 Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg/kg administered orally

    Arm title
    		 Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Arm description
    		 Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid phosphate
    Investigational medicinal product code
    Other name
    MK-1986, TR-701 FA, Sivextro
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    3 mg/kg administered orally

    Number of subjects in period 1
    		Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Started
    5
    5
    5
    5
    6
    6
    Completed
    5
    5
    4
    5
    6
    6
    Not completed
    0
    0
    1
    0
    0
    0
         Lost to follow-up
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 3: Tedizolid oral 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years) Total
    Number of subjects
    		 5 5 5 5 6 6 32
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 5 5 5 5 6 6 32
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.2 ± 1.3 7.4 ± 1.1 3.4 ± 0.5 4.0 ± 1.4 8.5 ± 1.8 3.2 ± 1.0 -
    Gender Categorical
    Units: Subjects
        Female
    		 1 2 1 3 2 4 13
        Male
    		 4 3 4 2 4 2 19
    Race
    Units: Subjects
        Black or African American
    		 1 2 0 0 1 0 4
        Multiple
    		 0 0 0 0 1 1 2
        White
    		 4 3 5 5 4 5 26
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 1 2 0 3 2 11
        Not Hispanic or Latino
    		 2 4 3 5 3 4 21

    End points

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    End points reporting groups
    Reporting group title
    Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 3: Tedizolid oral 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Subject analysis set title
    IV Administration Groups 1 & 2: Tedizolid 3-6 mg/kg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single intravenous infusion of tedizolid phosphate dosed at 3-6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Subject analysis set title
    Oral Administration Groups 3 & 4: Tedizolid oral 3-4 mg/kg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received a single dose of tedizolid phosphate oral suspension dosed at 3-4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Primary: Maximum observed drug concentration in plasma (Cmax) of tedizolid phosphate (prodrug)

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    End point title
    		 Maximum observed drug concentration in plasma (Cmax) of tedizolid phosphate (prodrug) [1]
    End point description
    Cmax of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Geometric mean is the geometric least squares mean. Analysis population includes all participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate. 9999: all participants' results in the group were below the lower limit of quantification. 8888: 95% CI cannot be calculated for a population containing a single participant.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    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 statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    4
    5
    5
    4
    6
    1
    Units: ng/mL
        geometric mean (confidence interval 95%)
    76.3 (8.38 to 695)
    82.4 (11.4 to 595)
    710 (98.4 to 5130)
    234 (25.7 to 2140)
    9999 (-9999 to 9999)
    9.4 (-8888 to 8888)
    No statistical analyses for this end point

    Primary: Time to reach peak plasma concentration (Tmax) of tedizolid phosphate (prodrug)

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    End point title
    		 Time to reach peak plasma concentration (Tmax) of tedizolid phosphate (prodrug) [2]
    End point description
    Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate. 9999: all participants' results in the group were below the lower limit of quantification.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    4
    5
    5
    4
    6
    1
    Units: Hours
        median (full range (min-max))
    1.18 (1.07 to 2.07)
    1.10 (1.00 to 1.33)
    1.12 (1.07 to 1.17)
    1.02 (1.00 to 1.05)
    9999 (-9999 to 9999)
    6.0 (6.0 to 6.0)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration time curve (AUC) of tedizolid phosphate (prodrug) from time zero to last detectable measurement

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    End point title
    		 Area under the plasma concentration time curve (AUC) of tedizolid phosphate (prodrug) from time zero to last detectable measurement [3]
    End point description
    Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. 9999: all participants' results in the group were below the lower limit of quantification. 8888: 95% CI cannot be calculated for a population containing a single participant
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    4
    5
    5
    4
    6
    1
    Units: hr*ng/mL
        geometric mean (confidence interval 95%)
    64.8 (6.42 to 654)
    63.6 (8.04 to 503)
    433 (54.8 to 3430)
    182 (18.1 to 1840)
    9999 (-9999 to 9999)
    14.1 (-8888 to 8888)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration time curve (AUC) of tedizolid phosphate (prodrug) from time zero to infinity

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    End point title
    		 Area under the plasma concentration time curve (AUC) of tedizolid phosphate (prodrug) from time zero to infinity [4]
    End point description
    Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure. 9999: all participants' results in the group were below the lower limit of quantification.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    1
    6
    6
    Units: hr*ng/mL
        median (full range (min-max))
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    2000 (2000 to 2000)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    No statistical analyses for this end point

    Primary: Terminal elimination half-life (T1/2) of tedizolid phosphate (prodrug)

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    End point title
    		 Terminal elimination half-life (T1/2) of tedizolid phosphate (prodrug) [5]
    End point description
    Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the T1/2. 9999: all participants' results in the group were below the lower limit of quantification. 8888: geometric coefficient of variation cannot be calculated for a population containing a single participant.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    1
    6
    6
    Units: Hours
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    2.77 ± 8888
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Primary: Clearance (CL) of tedizolid phosphate (prodrug) in participants who received tedizolid phosphate intravenously (IV)

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    End point title
    		 Clearance (CL) of tedizolid phosphate (prodrug) in participants who received tedizolid phosphate intravenously (IV) [6] [7]
    End point description
    CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Analysis population includes all participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure. 9999: all participants' results in the group were below the lower limit of quantification. 8888: geometric coefficient of variation cannot be calculated for a population containing a single participant.
    End point type
    Primary
    End point timeframe
    Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [7] - 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: This endpoint reports the CL for the IV dose only.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    1
    Units: mL/hr
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    24400 ± 8888
    No statistical analyses for this end point

    Primary: Clearance (CL/F) of tedizolid phosphate in participants who received oral tedizolid phosphate (prodrug)

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    End point title
    		 Clearance (CL/F) of tedizolid phosphate in participants who received oral tedizolid phosphate (prodrug) [8] [9]
    End point description
    CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Analysis population includes all participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL/F. All orally dosed participants' data were below the lower limit of quantification, resulting in no reportable data. 9999: all participants' results in the group were below the lower limit of quantification.
    End point type
    Primary
    End point timeframe
    Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose
    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 statistical analyses 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: This endpoint reports the CL/F for the oral dose only.
    End point values
    		 Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    6
    6
    Units: mL/hr/kg
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Primary: Maximum observed drug concentration in plasma (Cmax) of tedizolid (the active metabolite)

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    End point title
    		 Maximum observed drug concentration in plasma (Cmax) of tedizolid (the active metabolite) [10]
    End point description
    Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    6
    Units: ng/mL
        geometric mean (confidence interval 95%)
    4960 (3440 to 7140)
    4140 (2880 to 5970)
    7460 (5180 to 10800)
    4190 (2910 to 6030)
    2590 (1860 to 3620)
    1820 (1310 to 2550)
    No statistical analyses for this end point

    Primary: Time to reach peak plasma concentration (Tmax) of tedizolid (the active metabolite)

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    End point title
    		 Time to reach peak plasma concentration (Tmax) of tedizolid (the active metabolite) [11]
    End point description
    Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    6
    Units: Hours
        median (full range (min-max))
    1.18 (1.07 to 1.50)
    1.10 (1.00 to 1.33)
    1.12 (1.07 to 1.17)
    1.00 (1.00 to 1.05)
    2.53 (1.20 to 6.02)
    3.08 (3.00 to 12.00)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement

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    End point title
    		 Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement [12]
    End point description
    Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    6
    Units: hr*ng/mL
        geometric mean (confidence interval 95%)
    28200 (21200 to 37600)
    19700 (14800 to 26200)
    26800 (20200 to 35800)
    17100 (12800 to 22700)
    22700 (17500 to 29500)
    14600 (11200 to 18900)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity

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    End point title
    		 Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity [13]
    End point description
    Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Geometric mean is the geometric least squares mean. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    5
    Units: hr*ng/mL
        geometric mean (confidence interval 95%)
    29600 (22500 to 38900)
    21000 (16000 to 27600)
    27300 (20800 to 35900)
    17300 (13200 to 22700)
    24900 (19400 to 32000)
    17200 (13100 to 22600)
    No statistical analyses for this end point

    Primary: Terminal elimination half-life (T1/2) of tedizolid (active metabolite)

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    End point title
    		 Terminal elimination half-life (T1/2) of tedizolid (active metabolite) [14]
    End point description
    Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the T1/2. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    5
    Units: Hours
        geometric mean (geometric coefficient of variation)
    5.18 ± 21.54
    4.93 ± 13.82
    5.51 ± 30.16
    5.76 ± 29.20
    6.15 ± 24.41
    6.79 ± 10.85
    No statistical analyses for this end point

    Primary: Clearance (CL) of tedizolid (active metabolite) in participants who received tedizolid phosphate intravenously (IV)

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    End point title
    		 Clearance (CL) of tedizolid (active metabolite) in participants who received tedizolid phosphate intravenously (IV) [15] [16]
    End point description
    CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Analysis population includes all participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL.
    End point type
    Primary
    End point timeframe
    Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours.
    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 statistical analyses 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: This endpoint reports the CL for the IV dose only.
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    Units: mL/hr
        geometric mean (geometric coefficient of variation)
    4164.60 ± 36.39
    4145.73 ± 73.21
    2582.66 ± 20.64
    2461.08 ± 11.99
    No statistical analyses for this end point

    Primary: Clearance (CL/F) of tedizolid (active metabolite) in participants who received oral tedizolid phosphate

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    End point title
    		 Clearance (CL/F) of tedizolid (active metabolite) in participants who received oral tedizolid phosphate [17] [18]
    End point description
    CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Analysis population includes all participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL/F.
    End point type
    Primary
    End point timeframe
    Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [18] - 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: This endpoint reports the CL/F for the oral dose only.
    End point values
    		 Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    6
    5
    Units: mL/hr/kg
        geometric mean (geometric coefficient of variation)
    4073.32 ± 21.14
    2090.77 ± 50.27
    No statistical analyses for this end point

    Primary: Dose normalized area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity

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    End point title
    		 Dose normalized area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity
    End point description
    The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome pooled groups by administration route. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after dose. Geometric mean is the geometric least squares mean. Analysis population includes all participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC.
    End point type
    Primary
    End point timeframe
    IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.
    End point values
    		 IV Administration Groups 1 & 2: Tedizolid 3-6 mg/kg Oral Administration Groups 3 & 4: Tedizolid oral 3-4 mg/kg
    Number of subjects analysed
    20
    11
    Units: hr*ng/mL/mg/kg
        geometric mean (confidence interval 95%)
    5340 (4680 to 6100)
    6000 (5020 to 7180)
    Statistical analysis title
    		 Bioavailability of Tedizolid
    Statistical analysis description
    Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.
    Comparison groups
    IV Administration Groups 1 & 2: Tedizolid 3-6 mg/kg v Oral Administration Groups 3 & 4: Tedizolid oral 3-4 mg/kg
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 Geometric least squares mean ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.35
    Notes
    [19] - The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.

    Secondary: Number of participants who experienced at least one adverse event

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    End point title
    		 Number of participants who experienced at least one adverse event
    End point description
    An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Analysis population includes all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    Up to 9 days
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    6
    Units: Participants
    2
    1
    2
    0
    3
    1
    No statistical analyses for this end point

    Secondary: Number of participants who discontinued study drug due to an adverse event

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    End point title
    		 Number of participants who discontinued study drug due to an adverse event
    End point description
    An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Analysis population includes all participants who received any study drug.
    End point type
    Secondary
    End point timeframe
    1 day
    End point values
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    5
    5
    5
    5
    6
    6
    Units: Participants
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Palatability of oral tedizolid phosphate suspension in participants who received oral tedizolid phosphate

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    End point title
    		 Palatability of oral tedizolid phosphate suspension in participants who received oral tedizolid phosphate [20]
    End point description
    Palatability of oral tedizolid phosphate suspension in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug. Analysis population includes all participants who received an oral dose of tedizolid phosphate suspension.
    End point type
    Secondary
    End point timeframe
    Following single oral dose on Day 1
    Notes
    [20] - 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: This endpoint reports the palatability for the oral dose only.
    End point values
    		 Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Number of subjects analysed
    6
    6
    Units: Participants
        Very good
    0
    0
        Good
    0
    1
        Neither good nor bad
    3
    2
        Bad
    1
    3
        Very bad
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 9 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 3: Tedizolid oral 4 mg/kg (6 to <12 years)
    Reporting group description
    		 Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Reporting group title
    Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Reporting group description
    		 Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

    Serious adverse events
    		 Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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: Tedizolid IV 5 mg/kg (6 to <12 years) Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 5 (0.00%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    Investigations
    Blood pressure systolic decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Heart rate decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Respiratory rate increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Incision site swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Dystonia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2016
    Amendment 1: primary reason for this amendment was to define events of clinical interest, revise exclusions and concomitant medications, clarify dosing, and modify sampling time points.
    25 Apr 2017
    Amendment 2: primary reason for this amendment was to revise inclusion and exclusion criteria, and clarify events of clinical interest.
    25 Apr 2017
    Amendment 3: primary reason for this amendment was to revise exclusion criterion and disallowed concomitant medications.
    14 Jul 2017
    Amendment 4: the primary reason for this amendment was to update dosing and alternative enrollment sequences for both older and younger age groups.

    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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