Gram-Positive Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
DRUGOral Suspension Tedizolid Phosphate
A single dose of tedizolid phosphate administered as an oral suspension.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No
Inclusion criteria
* Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity. * Is at least 1 kg in weight. * Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations. * Has no clinically significant ECG abnormalities. * Has sufficient vascular access to receive trial drug, and allow for required blood draws. * Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable.
Exclusion criteria
* Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator. * Has used rifampin within 14 days prior to dosing. * Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing.. * Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease. * Has a history of drug allergy or hypersensitivity to oxazolidinones. * Has had significant blood loss. * Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug. * Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study. * Has received another investigational product within the 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1, 3, 5, 8, 12, and 24 hours post start of dosing | 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. |
| Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1, 3, 5, 8, 12, and 24 hours post start of dosing | 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. |
| Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1, 3, 5, 8, 12, and 24 hours post start of dosing | 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. |
| Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1, 1.5, 3, 6, 12 and 24 hours post start of dosing | 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. |
| Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last] | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing | 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. |
| 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] | 1, 3, 5, 8, 12, and 24 hours post start of dosing | 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. |
| Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1, 3, 5, 8, 12, and 24 hours post start of dosing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Discontinued Study Treatment Due to an AE | Up to approximately 3 days | 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. |
| Number of Participants With an Adverse Event (AE) | Up to approximately 21 days | 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. |
Countries
Bulgaria, Colombia, Norway, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 30 centers in 5 countries.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 6 |
| 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. | 8 |
| 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. | 4 |
| 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. | 9 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| Total | 47 |
Baseline characteristics
| Characteristic | Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 Days to <6 Months | Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 Months to <24 Months | Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.3 Days STANDARD_DEVIATION 9.9 | 420.7 Days STANDARD_DEVIATION 167.1 | 8.3 Days STANDARD_DEVIATION 9.4 | 11.8 Days STANDARD_DEVIATION 11.3 | 9.9 Days STANDARD_DEVIATION 7.9 | 2.0 Days STANDARD_DEVIATION 1.2 | 289.0 Days STANDARD_DEVIATION 165.5 | 13.0 Days STANDARD_DEVIATION 11.7 | 6.5 Days STANDARD_DEVIATION 6.4 | 88.8 Days STANDARD_DEVIATION 165.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 7 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 1 Participants | 1 Participants | 5 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 6 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants | 1 Participants | 6 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 26 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 5 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 3 Participants | 3 Participants | 6 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 | 0 / 8 | 0 / 4 | 0 / 9 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 1 / 6 | 0 / 8 | 0 / 4 | 2 / 9 | 2 / 4 | 1 / 4 | 0 / 4 | 1 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 6 | 0 / 8 | 0 / 4 | 0 / 9 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). t1/2 for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr*μg/mL |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. AUC0-last for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 10.5 hr*μg/mL |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 7.48 hr*μg/mL |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 13.6 hr*μg/mL | Geometric Coefficient of Variation 42.4 |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 8.23 hr*μg/mL | Geometric Coefficient of Variation 115.9 |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last] | 15.6 hr*μg/mL | Geometric Coefficient of Variation 17.6 |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to the scientific model. Protocol specified PK sampling didn't characterize terminal elimination phase; thus, this couldn't be estimated for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2). AUC0-inf for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and reported separately.
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 14.3 hr*μg/mL | Geometric Coefficient of Variation 40.4 |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 9.21 hr*μg/mL | Geometric Coefficient of Variation 128.2 |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 17.8 hr*μg/mL | Geometric Coefficient of Variation 20.9 |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. AUC0-inf for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | NA hr*μg/mL |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. AUC0-last for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | NA hr*μg/mL |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. Cmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 1.82 μg/mL |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 1.69 μg/mL |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 2.19 μg/mL | Geometric Coefficient of Variation 51 |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 0.962 μg/mL | Geometric Coefficient of Variation 71.9 |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1.35 μg/mL | Geometric Coefficient of Variation 44.5 |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. Cmax for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | NA μg/mL |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA μg/mL |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA μg/mL |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA μg/mL |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to the scientific model. Protocol specified PK sampling didn't characterize terminal elimination phase; thus, this couldn't be estimated for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2). t1/2 for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and reported separately.
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). t1/2 for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 4.17 hr | Geometric Coefficient of Variation 47.7 |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 6.63 hr | Geometric Coefficient of Variation 38 |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 7.08 hr | Geometric Coefficient of Variation 41.2 |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. t1/2 for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | NA hr |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration | NA hr |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with protocol to ensure that data exhibits treatment effects, according to scientific model and had data available for this outcome. Tmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 1.60 hr |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate | 1.08 hr |
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.
Time frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data would exhibit treatment effects, according to the scientific model and had data available for this outcome. Per protocol, Group 1 PK outcome analysis was done irrespective of age, across Cohorts 1 and 2 (28 days to \<24 months). Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) are excluded and have been reported separately.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1.33 hr |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1.41 hr |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate | 1.50 hr |
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.
Time frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects and had data available for this outcome. Tmax for single dose (Part A Group 1 \[Cohorts 1 \& 2\], Group 2 Cohort 1, Group 3 Cohort 1) are excluded and have been reported separately. Tedizolid phosphate PK analysis was not done in Part B, per protocol. Group 2 Cohort 2 participants didn't meet the per protocol analysis population criteria and were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration | NA hr |
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.
Time frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. AUC0-last for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension [AUC0-last] | 7.92 hr*μg/mL |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | 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] | 9.25 hr*μg/mL |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | 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] | 14.9 hr*μg/mL |
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.
Time frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. AUC0-inf for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 8.36 hr*μg/mL |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 9.44 hr*μg/mL |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 22.1 hr*μg/mL |
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.
Time frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. Cmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1.32 μg/mL |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 0.899 μg/mL |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1.22 μg/mL |
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.
Time frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. t1/2 for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 5.73 hr |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 3.82 hr |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 13.4 hr |
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.
Time frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Population: The subset of participants who complied with the protocol to ensure that data exhibits treatment effects, according to the scientific model and had data available for this outcome. Tmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) are excluded and have been reported separately.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 1 hr |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 3.03 hr |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension | 8 hr |
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.
Time frame: Up to approximately 3 days
Population: All participants who received at least one dose of the investigational drug were assessed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants That Discontinued Study Treatment Due to an AE | 0 Participants |
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.
Time frame: Up to approximately 21 days
Population: All participants who received at least one dose of the investigational drug were assessed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Cohorts 1+2:SD IV Tedizolid Phosphate 28days-<24months | Number of Participants With an Adverse Event (AE) | 1 Participants |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 1 Participants |
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 0 Participants |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 0 Participants |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (Preterm) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 2 Participants |
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 Days to <24 Months | Number of Participants With an Adverse Event (AE) | 2 Participants |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (Full Term) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 1 Participants |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 0 Participants |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (Preterm) Birth to <28 Days | Number of Participants With an Adverse Event (AE) | 1 Participants |