Trial Outcomes & Findings for A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014) (NCT NCT03217565)

Results Overview

AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of pharmacokinetic (PK) outcomes 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, tedizolid phosphate AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

47 participants

Primary outcome timeframe

1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Results posted on

2025-02-11

Participant Flow

This study was conducted at 30 centers in 5 countries.

Participant milestones

Participant milestones
Measure	Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months 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.	Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Overall Study STARTED	4	6	8	4	9	4	4	4	4
Overall Study COMPLETED	4	6	8	4	9	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months n=4 Participants 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.	Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months n=6 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=8 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=9 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=4 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=4 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Continuous	51.3 Days STANDARD_DEVIATION 9.9 • n=5 Participants	420.7 Days STANDARD_DEVIATION 167.1 • n=7 Participants	8.3 Days STANDARD_DEVIATION 9.4 • n=5 Participants	11.8 Days STANDARD_DEVIATION 11.3 • n=4 Participants	9.9 Days STANDARD_DEVIATION 7.9 • n=21 Participants	2.0 Days STANDARD_DEVIATION 1.2 • n=8 Participants	289.0 Days STANDARD_DEVIATION 165.5 • n=8 Participants	13.0 Days STANDARD_DEVIATION 11.7 • n=24 Participants	6.5 Days STANDARD_DEVIATION 6.4 • n=42 Participants	88.8 Days STANDARD_DEVIATION 165.7 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	29 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	20 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	26 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	26 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	19 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.

AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of pharmacokinetic (PK) outcomes 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, tedizolid phosphate AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=3 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
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	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations below level of quantification (BLOQ).	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type could not be estimated per protocol due to plasma concentrations BLOQ. Method of dispersion not applicable due to low number of participants analyzed.	—	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations below level of quantification (BLOQ).	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.

AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes 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, tedizolid phosphate AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=3 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type could not be estimated per protocol due to plasma concentrations BLOQ. Method of dispersion not applicable due to low number of participants analyzed.	—	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.

Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes 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, tedizolid phosphate Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=3 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	NA μg/mL Geometric Coefficient of Variation NA Measure type could not be estimated per protocol due to plasma concentrations BLOQ. Method of dispersion not applicable due to low number of participants analyzed.	—	NA μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.

Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes 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, tedizolid phosphate Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=3 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA hr Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	NA hr Measure type could not be estimated per protocol due to plasma concentrations BLOQ. Method of dispersion not applicable due to low number of participants analyzed.	—	NA hr Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). t1/2 for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.

t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes 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, tedizolid phosphate t½ for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=3 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA hr Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	NA hr Geometric Coefficient of Variation NA Measure type could not be estimated per protocol due to plasma concentrations BLOQ. Method of dispersion not applicable due to low number of participants analyzed.	—	NA hr Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. AUC0-last for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.

AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate 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 outcome 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 outcome and were excluded from this protocol-specified analysis.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=2 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	—	—	—	—	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. AUC0-inf for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.

AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate 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 outcome 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=2 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	—	—	—	—	NA hr*μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. Cmax for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.

Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate 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 outcome 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 outcome and were excluded from this protocol-specified analysis.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=2 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	—	—	—	—	NA μg/mL Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. Tmax for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.

Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate 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 outcome 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 outcome and were excluded from this protocol-specified analysis.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=2 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	—	—	—	—	NA hr Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. t1/2 for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.

t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate 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 outcome 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 outcome and were excluded from this protocol-specified analysis.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=2 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	—	—	—	—	NA hr Geometric Coefficient of Variation NA Measure type and method of dispersion could not be estimated per protocol due to plasma concentrations BLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.

AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=10 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=5 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last]	13.6 hr*μg/mL Geometric Coefficient of Variation 42.4	8.23 hr*μg/mL Geometric Coefficient of Variation 115.9	—	15.6 hr*μg/mL Geometric Coefficient of Variation 17.6	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.

AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=10 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=5 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	14.3 hr*μg/mL Geometric Coefficient of Variation 40.4	9.21 hr*μg/mL Geometric Coefficient of Variation 128.2	—	17.8 hr*μg/mL Geometric Coefficient of Variation 20.9	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.

Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=10 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=6 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=5 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	2.19 μg/mL Geometric Coefficient of Variation 51.0	0.962 μg/mL Geometric Coefficient of Variation 71.9	—	1.35 μg/mL Geometric Coefficient of Variation 44.5	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.

Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=10 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=6 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=5 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	1.33 hr Interval 1.0 to 1.58	1.41 hr Interval 1.0 to 2.5	—	1.50 hr Interval 1.08 to 6.53	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). t1/2 for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.

t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=10 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=5 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	4.17 hr Geometric Coefficient of Variation 47.7	6.63 hr Geometric Coefficient of Variation 38.0	—	7.08 hr Geometric Coefficient of Variation 41.2	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. 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 \[Groups 4, 5, 6\]) are excluded and have been reported separately.

AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=1 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last]	—	—	10.5 hr*μg/mL	—	7.48 hr*μg/mL	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. 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 \[Groups 4, 5, 6\]) are excluded and have been reported separately.

Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=1 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	—	—	1.82 μg/mL	—	1.69 μg/mL	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. 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 \[Groups 4, 5, 6\]) are excluded and have been reported separately.

Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=1 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=1 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	—	—	1.60 hr	—	1.08 hr	—	—	—	—

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to the scientific model. Protocol specified PK sampling didn't characterize terminal elimination phase; thus, this couldn't be estimated for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2). 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 \[Groups 4, 5, 6\]) are excluded and reported separately.

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. 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing

Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to the scientific model. Protocol specified PK sampling didn't characterize terminal elimination phase; thus, this couldn't be estimated for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2). t1/2 for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and reported separately.

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. 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1, 3, 5, 8, 12, and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. 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) are excluded and have been reported separately.

AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=3 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part B: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension [AUC0-last]	—	—	—	—	—	7.92 hr*μg/mL	9.25 hr*μg/mL	14.9 hr*μg/mL	—

PRIMARY outcome

Timeframe: 1, 3, 5, 8, 12, and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. 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) are excluded and have been reported separately.

AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=3 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	—	—	—	—	—	8.36 hr*μg/mL	9.44 hr*μg/mL	22.1 hr*μg/mL	—

PRIMARY outcome

Timeframe: 1, 3, 5, 8, 12, and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. 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) are excluded and have been reported separately.

Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=3 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	—	—	—	—	—	1.32 μg/mL	0.899 μg/mL	1.22 μg/mL	—

PRIMARY outcome

Timeframe: 1, 3, 5, 8, 12, and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. 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) are excluded and have been reported separately.

Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=3 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	—	—	—	—	—	1 hr	3.03 hr	8 hr	—

PRIMARY outcome

Timeframe: 1, 3, 5, 8, 12, and 24 hours post start of dosing

Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. t1/2 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) are excluded and have been reported separately.

t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. 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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=3 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=3 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days 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.
Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	—	—	—	—	—	5.73 hr	3.82 hr	13.4 hr	—

SECONDARY outcome

Timeframe: Up to approximately 21 days

Population: All participants who received at least one dose of the investigational drug were assessed.

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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=4 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=6 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=8 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=9 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=4 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.
Number of Participants With an Adverse Event (AE)	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 3 days

Population: All participants who received at least one dose of the investigational drug were assessed.

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.

Outcome measures

Outcome measures
Measure	Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months n=4 Participants 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=6 Participants 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=8 Participants 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=9 Participants 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=4 Participants 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 Participants 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.
Number of Participants That Discontinued Study Treatment Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months n=4 participants at risk 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.	Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months n=6 participants at risk 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=8 participants at risk 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 participants at risk 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=9 participants at risk 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=4 participants at risk 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=4 participants at risk 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 participants at risk 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 participants at risk 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.
General disorders Therapeutic product effect incomplete	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.

Other adverse events

Other adverse events
Measure	Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months n=4 participants at risk 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.	Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months n=6 participants at risk 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.	Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=8 participants at risk 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.	Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 participants at risk 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.	Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days n=9 participants at risk 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.	Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days n=4 participants at risk 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.	Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months n=4 participants at risk 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.	Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days n=4 participants at risk 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.	Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days n=4 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Eye disorders Swelling of eyelid	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Infections and infestations Conjunctivitis	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Infections and infestations Pneumonia	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	11.1% 1/9 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Infections and infestations Serratia sepsis	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Investigations Immature granulocyte count increased	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	25.0% 1/4 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/6 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	11.1% 1/9 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	16.7% 1/6 • Number of events 1 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/8 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/9 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.	0.00% 0/4 • Up to approximately 21 days Safety: All participants who received at least one dose of the investigational drug. All-cause mortality: All allocated participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60