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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1986-014 | Other Identifier | MSD Protocol Number | |
| 2017-000953-38 | EudraCT Number |
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The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.
Per protocol, PK analysis in Part A Group 1 will be conducted across ages in Cohorts 1 and 2 combined: Part A Group 1 Cohort 1 + Cohort 2: 28 days to <24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months | Experimental | Pediatric participants 28 days to <6 months of age will receive 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. |
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| Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months | Experimental | Pediatric participants 6 months to <24 months of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. |
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| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days | Experimental | Full term (FT) neonates from birth to <28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg. |
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| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days | Experimental | FT neonates from birth to <28 days of age will receive 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Tedizolid Phosphate | Drug | A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | 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. | Up to approximately 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital ( Site 1012) | Little Rock | Arkansas | 72202 | United States | ||
| Children's Hospital of Orange County ( Site 1001) |
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| Label | URL |
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| Merck Clinical Trials Information | View source |
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This study was conducted at 30 centers in 5 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2022 |
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| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days | Experimental | Preterm (PT) neonates from birth to <28 days of age will receive 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 | Experimental | PT neonates from birth to <28 days of age will receive 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. |
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| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months | Experimental | Pediatric participants 28 days to <24 months of age will receive 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. |
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| Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days | Experimental | FT neonates from birth to <28 days of age will receive 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. |
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| Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days | Experimental | PT neonates from birth to <28 days of age will receive 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. |
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| Oral Suspension Tedizolid Phosphate | Drug | A single dose of tedizolid phosphate administered as an oral suspension. |
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| Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
| Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
| 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] | 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. | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
| Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
| Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
| Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
| Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
| Number of Participants That Discontinued Study Treatment Due to an AE |
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. |
| Up to approximately 3 days |
| Orange |
| California |
| 92868 |
| United States |
| Sharp Memorial Hospital ( Site 1021) | San Diego | California | 92123 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022) | Chicago | Illinois | 60611 | United States |
| Our Lady of the Lake Regional Medical Center. ( Site 1004) | Baton Rouge | Louisiana | 70808 | United States |
| Saint Louis Children's Hospital ( Site 1020) | St Louis | Missouri | 63110 | United States |
| Primary Children's Hospital ( Site 1000) | Salt Lake City | Utah | 84113 | United States |
| Medical Center - 1- Sevlievo EOOD ( Site 2207) | Sevlievo | Gabrovo | 5400 | Bulgaria |
| MHAT Sv. Ivan Rilski EOOD ( Site 2201) | Kozloduy | Vratsa | 3320 | Bulgaria |
| UMHAT Deva Maria ( Site 2208) | Burgas | 8127 | Bulgaria |
| MHAT Dr. Tota Venkova-Pediatrics ( Site 2218) | Gabrovo | 5300 | Bulgaria |
| MHAT "Dr. Stamen Iliev" Montana ( Site 2215) | Montana | 3400 | Bulgaria |
| MHAT City Clinic Sv. Georgi EOOD ( Site 2202) | Montana | 3400 | Bulgaria |
| UMHAT Dr. Georgi Stranski EAD ( Site 2211) | Pleven | 5800 | Bulgaria |
| MHAT Rousse-Neonatology ( Site 2213) | Rousse | 7002 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Ruse ( Site 2204) | Rousse | 7002 | Bulgaria |
| UMHAT Kanev AD ( Site 2209) | Rousse | 7002 | Bulgaria |
| MHAT Dr. Ival Seliminski ( Site 2212) | Sliven | 8800 | Bulgaria |
| Hospital San Vicente Fundacion ( Site 1103) | MedellÃn | Antioquia | 050010 | Colombia |
| Clinica de la Costa S.A.S. ( Site 1106) | Barranquilla | Atlántico | 080020 | Colombia |
| Fundacion Hospital Infantil Universitario de San Jose ( Site 1107) | Bogotá | Bogota D.C. | 111221 | Colombia |
| Fundacion Valle del Lili ( Site 1102) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Akershus Universitetssykehus HF ( Site 1604) | Loerenskog | Akershus | 1478 | Norway |
| Haukeland Universitetssjukehus ( Site 1602) | Bergen | Hordaland | 5021 | Norway |
| Stavanger Universitetssykehus, Helse Stavanger ( Site 1601) | Stavanger | Rogaland | 4011 | Norway |
| St. Olavs Hospital. ( Site 1600) | Trondheim | Sor-Trondelag | 7006 | Norway |
| University Hospital Southampton NHS Foundation Trust ( Site 1700) | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703) | Liverpool | Lancashire | L12 2AP | United Kingdom |
| Royal Victoria Infirmary ( Site 1702) | Newcastle | Newcastle Upon Tyne | NE1 4LP | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust ( Site 1704) | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 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. | Posted | Median | Full Range | hr | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | 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. | Posted | Median | Full Range | hr | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Median | Full Range | hr | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing |
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| Primary | Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 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. | 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. | Posted | Number | hr*μg/mL | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Number | μg/mL | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Number | hr | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 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. | 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. | Posted | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing |
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| Primary | 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] | 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. | 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. | Posted | Number | hr*μg/mL | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
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| Primary | Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 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. | Posted | Number | hr*μg/mL | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
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| Primary | Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 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. | Posted | Number | μg/mL | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
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| Primary | Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 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. | Posted | Number | hr | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
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| Primary | Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 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. | 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. | Posted | Number | hr | 1, 3, 5, 8, 12, and 24 hours post start of dosing |
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| Secondary | Number of Participants With an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE was reported for each arm. | All participants who received at least one dose of the investigational drug were assessed. | Posted | Count of Participants | Participants | Up to approximately 21 days |
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| Secondary | Number of Participants That Discontinued Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported for each arm. | All participants who received at least one dose of the investigational drug were assessed. | Posted | Count of Participants | Participants | Up to approximately 3 days |
|
Up to approximately 21 days
Safety: All participants who received at least one dose of the investigational drug.
All-cause mortality: All allocated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 4 | 1 | 4 | 0 | 4 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | 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. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG005 | 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. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG006 | 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. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG007 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG008 | 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. | 0 | 4 | 0 | 4 | 1 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Therapeutic product effect incomplete | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Serratia sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Immature granulocyte count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jan 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
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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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
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