A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02750761
Collaborator
(none)
32
6
31.6
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Part A (IV):
-
Group 1 (Cohort 1 and Cohort 2) (6 to <12 years)
-
Group 2 (Cohort 1 and Cohort 2) (2 to <6 years)
Part B (Oral Suspension):
-
Group 3 (6 to <12 years)
-
Group 4 (2 to <6 years)
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old
Actual Study Start Date
:
May 2, 2016
Actual Primary Completion Date
:
Dec 16, 2018
Actual Study Completion Date
:
Dec 21, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Tedizolid Phosphate (IV)
200 mg/vial powder for injection
Other Names:
|
| Experimental: 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. |
Drug: Tedizolid Phosphate (IV)
200 mg/vial powder for injection
Other Names:
|
| Experimental: 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. |
Drug: Tedizolid Phosphate (IV)
200 mg/vial powder for injection
Other Names:
|
| Experimental: 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. |
Drug: Tedizolid Phosphate (IV)
200 mg/vial powder for injection
Other Names:
|
| Experimental: 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. |
Drug: Tedizolid Phosphate (oral suspension)
Powder for oral suspension 20 mg/mL following reconstitution
Other Names:
|
| Experimental: 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. |
Drug: Tedizolid Phosphate (oral suspension)
Powder for oral suspension 20 mg/mL following reconstitution
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug) [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.]
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.
- Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug) [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 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.
- Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement [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 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.
- Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity [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 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.
- Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug) [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 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.
- Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV) [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.]
CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).
- Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug) [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]
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).
- Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite) [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.]
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.
- Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite) [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 (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.
- Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement [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 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.
- Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity [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 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.
- Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite) [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) 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.
- Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV) [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.]
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).
- Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate [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]
CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4).
- Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity [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.]
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.
Secondary Outcome Measures
- Number of Participants Who Experienced at Least One Adverse Event [Up to 9 days]
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.
- Number of Participants Who Discontinued Study Drug Due to an Adverse Event [1 day]
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.
- Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate [Following single oral dose on Day 1]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
-
Weight >5th percentile and <95th percentile based on age;
-
Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
-
Females must be premenarchal, abstinent, or practicing an effective method of birth control;
Exclusion Criteria:
-
History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
-
Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
-
History of drug allergy or hypersensitivity to oxazolidinones;
-
Pregnant or breast feeding;
-
Significant blood loss within 60 days prior to study start;
-
Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
-
Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
-
Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
-
Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT02750761
Other Study ID Numbers:
- 1986-013
- TR701-120
- 2015-004595-29
- MK-1986-013
First Posted:
Apr 25, 2016
Last Update Posted:
Dec 20, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Period Title: Overall Study | ||||||
| STARTED | 5 | 5 | 5 | 5 | 6 | 6 |
| COMPLETED | 5 | 5 | 4 | 5 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. | Total of all reporting groups |
| Overall Participants | 5 | 5 | 5 | 5 | 6 | 6 | 32 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
8.2
(1.3)
|
7.4
(1.1)
|
3.4
(0.5)
|
4.0
(1.4)
|
8.5
(1.8)
|
3.2
(1.0)
|
5.8
(2.6)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
1
20%
|
2
40%
|
1
20%
|
3
60%
|
2
33.3%
|
4
66.7%
|
13
40.6%
|
| Male |
4
80%
|
3
60%
|
4
80%
|
2
40%
|
4
66.7%
|
2
33.3%
|
19
59.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
3
60%
|
1
20%
|
2
40%
|
0
0%
|
3
50%
|
2
33.3%
|
11
34.4%
|
| Not Hispanic or Latino |
2
40%
|
4
80%
|
3
60%
|
5
100%
|
3
50%
|
4
66.7%
|
21
65.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
20%
|
2
40%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
4
12.5%
|
| White |
4
80%
|
3
60%
|
5
100%
|
5
100%
|
4
66.7%
|
5
83.3%
|
26
81.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
16.7%
|
2
6.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug) |
|---|---|
| Description | Cmax of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 4 | 5 | 5 | 4 | 6 | 1 |
| Geometric Least Squares Mean (95% Confidence Interval) [ng/mL] |
76.3
|
82.4
|
710
|
234
|
NA
|
9.4
|
| Title | Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug) |
|---|---|
| Description | Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 4 | 5 | 5 | 4 | 6 | 1 |
| Median (Full Range) [Hours] |
1.18
|
1.10
|
1.12
|
1.02
|
NA
|
6.0
|
| Title | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement |
|---|---|
| Description | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 4 | 5 | 5 | 4 | 6 | 1 |
| Geometric Least Squares Mean (95% Confidence Interval) [hr*ng/mL] |
64.8
|
63.6
|
433
|
182
|
NA
|
14.1
|
| Title | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity |
|---|---|
| Description | Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 1 | 6 | 6 |
| Median (Full Range) [hr*ng/mL] |
NA
|
NA
|
NA
|
2000
|
NA
|
NA
|
| Title | Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug) |
|---|---|
| Description | Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 1 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [Hours] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
2.77
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Title | Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV) |
|---|---|
| Description | CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/hr] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
24400
(NA)
|
| Title | Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug) |
|---|---|
| Description | CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. |
| Measure Participants | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/hr/kg] |
NA
(NA)
|
NA
(NA)
|
| Title | Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite) |
|---|---|
| Description | Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 6 |
| Geometric Least Squares Mean (95% Confidence Interval) [ng/mL] |
4960
(3440)
|
4140
(2880)
|
7460
(5180)
|
4190
(2910)
|
2590
(1860)
|
1820
(1310)
|
| Title | Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite) |
|---|---|
| Description | Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 6 |
| Median (Full Range) [Hours] |
1.18
(1.07)
|
1.10
(1.00)
|
1.12
(1.07)
|
1.00
(1.00)
|
2.53
(1.20)
|
3.08
(3.00)
|
| Title | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement |
|---|---|
| Description | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 6 |
| Geometric Least Squares Mean (95% Confidence Interval) [hr*ng/mL] |
28200
(21200)
|
19700
(14800)
|
26800
(20200)
|
17100
(12800)
|
22700
(17500)
|
14600
(11200)
|
| Title | Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity |
|---|---|
| Description | Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 5 |
| Geometric Least Squares Mean (95% Confidence Interval) [hr*ng/mL] |
29600
|
21000
|
27300
|
17300
|
24900
|
17200
|
| Title | Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite) |
|---|---|
| Description | Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [Hours] |
5.18
(21.54)
|
4.93
(13.82)
|
5.51
(30.16)
|
5.76
(29.20)
|
6.15
(24.41)
|
6.79
(10.85)
|
| Title | Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV) |
|---|---|
| Description | CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/hr] |
4164.60
(36.39)
|
4145.73
(73.21)
|
2582.66
(20.64)
|
2461.08
(11.99)
|
| Title | Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate |
|---|---|
| Description | CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. |
| Measure Participants | 6 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [mL/hr/kg] |
4073.32
(21.14)
|
2090.77
(50.27)
|
| Title | Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity |
|---|---|
| Description | The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome 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. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | IV Group | Oral Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 20 | 11 |
| Geometric Least Squares Mean (95% Confidence Interval) [hr*ng/mL/mg/kg] |
5340
|
6000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years), Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric Least Squares Mean Ratio |
| Estimated Value | 1.12 | |
| Confidence Interval |
(2-Sided) 90% 0.93 to 1.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator. | |
| Title | Number of Participants Who Experienced at Least One Adverse Event |
|---|---|
| Description | An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Time Frame | Up to 9 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received any study drug. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 6 |
| Count of Participants [Participants] |
2
40%
|
1
20%
|
2
40%
|
0
0%
|
3
50%
|
1
16.7%
|
| Title | Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
|---|---|
| Description | An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received any study drug. |
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. |
| Measure Participants | 5 | 5 | 5 | 5 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate |
|---|---|
| Description | Palatability of oral tedizolid phosphate suspension in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug. |
| Time Frame | Following single oral dose on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received an oral dose of tedizolid phosphate suspension. |
| Arm/Group Title | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years) |
|---|---|---|
| Arm/Group Description | Participants 6 to <12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. |
| Measure Participants | 6 | 6 |
| Very good |
0
0%
|
0
0%
|
| Good |
0
0%
|
1
20%
|
| Neither good nor bad |
3
60%
|
2
40%
|
| Bad |
1
20%
|
3
60%
|
| Very bad |
2
40%
|
0
0%
|
Adverse Events
| Time Frame | Up to 9 days | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) | ||||||
| Arm/Group Description | Participants 6 to <12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. | 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. | 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. | 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 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. | 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. | ||||||
All Cause Mortality |
||||||||||||
| Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Appendicitis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years) | Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years) | Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years) | Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years) | Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years) | Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/5 (40%) | 1/5 (20%) | 2/5 (40%) | 0/5 (0%) | 3/6 (50%) | 1/6 (16.7%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Tachycardia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Diarrhoea | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Faeces discoloured | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| Vomiting | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| General disorders | ||||||||||||
| Asthenia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Chest pain | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Pyrexia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Gastroenteritis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Incision site swelling | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Investigations | ||||||||||||
| Blood pressure systolic decreased | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Blood pressure systolic increased | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Haemoglobin decreased | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Heart rate decreased | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Respiratory rate increased | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Weight decreased | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Decreased appetite | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Musculoskeletal stiffness | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Dystonia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Headache | 0/5 (0%) | 0 | 1/5 (20%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Polyuria | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Epistaxis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT02750761
Other Study ID Numbers:
- 1986-013
- TR701-120
- 2015-004595-29
- MK-1986-013
First Posted:
Apr 25, 2016
Last Update Posted:
Dec 20, 2019
Last Verified:
Dec 1, 2019