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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-120 | Other Identifier | Cubist Protocol Number | |
| 2015-004595-29 | EudraCT Number | ||
| MK-1986-013 | Other Identifier | Merck Protocol Number |
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This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B) administration to hospitalized participants ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4, respectively).
Part A (IV):
Part B (Oral Suspension):
In Cohort 1 of Group 1 (IV) participants received a single administration of tedizolid phosphate at 5 mg/kg of total body weight. After all participants in Cohort 1 of Group 1 received study drug, a preliminary analysis of the safety and PK data was performed and results were used to select 4 mg/kg as the appropriate dose for Cohort 2 of Group 1 and Group 3, and to select 6 mg/kg as the starting dose for the younger participants, Cohort 1 of Group 2. After all participants in Cohort 1 of Group 2 receive study drug, another preliminary analysis of the safety and PK data will be performed and results will be used to confirm 6 mg/kg as the appropriate dose for Cohort 2 of Group 2. Similarly, the Group 4 dose will be confirmed after data review of Group 3 results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) | Experimental | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) | Experimental | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) | Experimental | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) | Experimental | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid Phosphate (IV) | Drug | 200 mg/vial powder for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug) | Cmax of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug) | Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 9 days |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33710976 | Derived | Arrieta AC, Ang JY, Espinosa C, Fofanov O, Tondel C, Chou MZ, De Anda CS, Kim JY, Li D, Sabato P, Sears PS, Bradley JS. Pharmacokinetics and Safety of Single-dose Tedizolid Phosphate in Children 2 to <12 Years of Age. Pediatr Infect Dis J. 2021 Apr 1;40(4):317-323. doi: 10.1097/INF.0000000000003030. |
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Prior to enrollment, participants were receiving prophylaxis for or with a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| FG001 | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) |
| 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 | Jun 23, 2017 |
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Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Group 4: Tedizolid oral 3 mg/kg (2 to <6 years) | Experimental | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| Tedizolid Phosphate (oral suspension) | Drug | Powder for oral suspension 20 mg/mL following reconstitution |
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| IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug) | Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV) | CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). | Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours. |
| Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug) | CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). | Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose |
| Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite) | Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite) | Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite) | Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
| Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV) | CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). | Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours. |
| Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate | CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). | Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose |
| Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity | The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome used pooled groups as follows: The IV Group pooled Groups 1 and 2, who received tedizolid phosphate via intravenous (IV) administration; the Oral Group pooled groups 3 and 4, who received tedizolid phosphate via oral administration. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| 1 day |
| Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate | Palatability of oral tedizolid phosphate suspension in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug. | Following single oral dose on Day 1 |
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| FG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| FG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| FG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| FG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG001 | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug) | Cmax of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug) | Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate. | Posted | Median | Full Range | Hours | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | hr*ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure. | Posted | Median | Full Range | hr*ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug) | Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the T1/2. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV) | CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). | All participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours. |
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| Primary | Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug) | CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). | All participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL/F. All orally dosed participants' data were below the lower limit of quantification, resulting in no reportable data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose |
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| Primary | Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite) | Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite) | Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid. | Posted | Median | Full Range | Hours | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | hr*ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | hr*ng/mL | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite) | Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the T1/2. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Primary | Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV) | CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). | All participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours. |
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| Primary | Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate | CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). | All participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL/F. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose |
|
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| Primary | Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity | The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome used pooled groups as follows: The IV Group pooled Groups 1 and 2, who received tedizolid phosphate via intravenous (IV) administration; the Oral Group pooled groups 3 and 4, who received tedizolid phosphate via oral administration. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. | All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC. Per protocol, participant arms were pooled based on route of administration (IV or Oral) and outcome was normalized to the dose received. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | hr*ng/mL/mg/kg | IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above. |
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| Secondary | Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All participants who received any study drug. | Posted | Count of Participants | Participants | Up to 9 days |
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| Secondary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All participants who received any study drug. | Posted | Count of Participants | Participants | 1 day |
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| Secondary | Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate | Palatability of oral tedizolid phosphate suspension in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug. | All participants who received an oral dose of tedizolid phosphate suspension. | Posted | Count of Participants | Participants | Following single oral dose on Day 1 |
|
Up to 9 days
Not provided
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 | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG001 | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 5 | 1 | 5 | 2 | 5 |
| EG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 0 | 6 | 0 | 6 | 1 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Incision site swelling | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood pressure systolic decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Respiratory rate increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
Sponsor intends to pursue publication of the results of the study in cooperation with a lead Investigator. Sponsor written approval is required for publication of any data subsets. Final authorship will be determined in accordance with the International Committee of Medical Journal Editors definition of authorship. Participant names and other personal data may not be disclosed in any publication without prior written authorization from Sponsor and the participant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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 |
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
| Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) |
Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
| OG002 | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
|
| Participants |
|
|
Combined group of participants from Groups 1-2. Participants 2 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3, 4, 5, or 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.
| OG001 | Oral Group | Combined group of participants from Groups 3-4. Participants 2 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 or 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
|
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| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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| OG003 | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG004 | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| OG005 | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Participants 2 to <6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
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