CompletedNCT02750761Updated Dec 20, 2019Results posted

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)

A Phase 1 interventional study of Tedizolid Phosphate (IV) and Tedizolid Phosphate (oral suspension) in Gram-Positive Bacterial Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-12-20.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Non-randomized
Ages: 2 Years to 11 Years
Sex: All

Study 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).

Read the 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.

Conditions studied

Gram-Positive Bacterial Infections

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Gram-Positive Bacterial Infections 49

In context

Gram-Positive Bacterial Infections

49 studies on the registry are indexed under Gram-Positive Bacterial Infections; 5 are open to participants now.

This study's enrollment of 32 is below the median of 86 across 35 interventional studies indexed under Gram-Positive Bacterial Infections.

Browse Gram-Positive Bacterial Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 11 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

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)
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)
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)
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)
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)
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)

Interventions

DrugTedizolid Phosphate (IV)
200 mg/vial powder for injection
Also known as: Sivextro, TR-701 FA, MK-1986
DrugTedizolid Phosphate (oral suspension)
Powder for oral suspension 20 mg/mL following reconstitution
Also known as: Sivextro, TR-701 FA, MK-1986

What researchers measure

Primary outcomes

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
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
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.
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.

Secondary outcomes

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.
Time frame: Up to 9 days
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.
Time frame: 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.
Time frame: Following single oral dose on Day 1

Results

Posted Dec 20, 2019

Participant flow

Participant flow — Overall Study
Milestone	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)
Started	5	5	5	5	6	6
Completed	5	5	4	5	6	6
Not completed	0	0	1	0	0	0
Withdrew: Lost to follow-up	0	0	1	0	0	0

Outcome measures

PrimaryMaximum 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.

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.
Reported as:: Geometric least squares mean · ng/mL

Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)
ng/mL	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)
Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)	76.3 (8.38 to 695)	82.4 (11.4 to 595)	710 (98.4 to 5130)	234 (25.7 to 2140)	NA (NA to NA)	9.4 (NA to NA)

PrimaryTime 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.

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.
Reported as:: Median · Hours

Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)
Hours	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)
Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)	1.18 (1.07 to 2.07)	1.10 (1.00 to 1.33)	1.12 (1.07 to 1.17)	1.02 (1.00 to 1.05)	NA (NA to NA)	6.0 (6.0 to 6.0)

PrimaryArea 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.

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.
Reported as:: Geometric least squares mean · hr*ng/mL

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement
hr*ng/mL	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)
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement	64.8 (6.42 to 654)	63.6 (8.04 to 503)	433 (54.8 to 3430)	182 (18.1 to 1840)	NA (NA to NA)	14.1 (NA to NA)

PrimaryArea 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.

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.
Reported as:: Median · hr*ng/mL

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity
hr*ng/mL	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)
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	2000 (2000 to 2000)	NA (NA to NA)	NA (NA to NA)

PrimaryTerminal 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.

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.
Reported as:: Geometric mean · Hours

Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)
Hours	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)
Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)	NA ± NA	NA ± NA	NA ± NA	2.77 ± NA	NA ± NA	NA ± NA

PrimaryClearance (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).

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.
Reported as:: Geometric mean · mL/hr

Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)
mL/hr	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)
Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)	NA ± NA	NA ± NA	NA ± NA	24400 ± NA

PrimaryClearance (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).

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
Reported as:: Geometric mean · mL/hr/kg

Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)
mL/hr/kg	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)
Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)	NA ± NA	NA ± NA

PrimaryMaximum 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.

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.
Reported as:: Geometric least squares mean · ng/mL

Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)
ng/mL	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)
Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)	4960 ± 3440	4140 ± 2880	7460 ± 5180	4190 ± 2910	2590 ± 1860	1820 ± 1310

PrimaryTime 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.

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.
Reported as:: Median · Hours

Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)
Hours	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)
Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)	1.18 ± 1.07	1.10 ± 1.00	1.12 ± 1.07	1.00 ± 1.00	2.53 ± 1.20	3.08 ± 3.00

PrimaryArea 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.

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.
Reported as:: Geometric least squares mean · hr*ng/mL

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement
hr*ng/mL	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)
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement	28200 ± 21200	19700 ± 14800	26800 ± 20200	17100 ± 12800	22700 ± 17500	14600 ± 11200

PrimaryArea 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.

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.
Reported as:: Geometric least squares mean · hr*ng/mL

Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity
hr*ng/mL	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)
Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity	29600 (22500 to 38900)	21000 (16000 to 27600)	27300 (20800 to 35900)	17300 (13200 to 22700)	24900 (19400 to 32000)	17200 (13100 to 22600)

PrimaryTerminal 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.

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.
Reported as:: Geometric mean · Hours

Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)
Hours	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)
Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)	5.18 ± 21.54	4.93 ± 13.82	5.51 ± 30.16	5.76 ± 29.20	6.15 ± 24.41	6.79 ± 10.85

PrimaryClearance (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).

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.
Reported as:: Geometric mean · mL/hr

Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)
mL/hr	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)
Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)	4164.60 ± 36.39	4145.73 ± 73.21	2582.66 ± 20.64	2461.08 ± 11.99

PrimaryClearance (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).

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
Reported as:: Geometric mean · mL/hr/kg

Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate
mL/hr/kg	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)
Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate	4073.32 ± 21.14	2090.77 ± 50.27

PrimaryDose 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.

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.
Reported as:: Geometric least squares mean · hr*ng/mL/mg/kg

Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity
hr*ng/mL/mg/kg	IV Group	Oral Group
Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity	5340 (4680 to 6100)	6000 (5020 to 7180)

Statistical analysis

IV Group vs Oral Group · Geometric least squares mean ratio: 1.12 · 90% CI 0.93 to 1.35The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.

SecondaryNumber 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.

Time frame:: Up to 9 days
Reported as:: Count of participants · Participants

Number of Participants Who Experienced at Least One Adverse Event
Participants	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)
Number of Participants Who Experienced at Least One Adverse Event	2	1	2	0	3	1

SecondaryNumber 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.

Time frame:: 1 day
Reported as:: Count of participants · Participants

Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Participants	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)
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0	0	0	0	0	0

SecondaryPalatability 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.

Time frame:: Following single oral dose on Day 1
Reported as:: Count of participants · Participants

Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate
Participants	Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	Group 4: Tedizolid Oral 3 mg/kg (2 to <6 Years)
Very good	0	0
Good	0	1
Neither good nor bad	3	2
Bad	1	3
Very bad	2	0

Adverse events

Collected over Up to 9 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)	0/5 (0%)	0/5 (0%)	2/5 (40%)
Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)	0/5 (0%)	0/5 (0%)	1/5 (20%)
Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 Years)	0/5 (0%)	1/5 (20%)	2/5 (40%)
Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 Years)	0/5 (0%)	0/5 (0%)	0/5 (0%)
Group 3: Tedizolid Oral 4 mg/kg (6 to <12 Years)	0/6 (0%)	0/6 (0%)	3/6 (50%)
Group 4: Tedizolid Oral 3 mg/kg (6 to <12 Years)	0/6 (0%)	0/6 (0%)	1/6 (16.7%)

Most frequent serious events

Most frequent serious events
Event	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)
AppendicitisInfections and infestations	0/5	0/5	1/5	0/5	0/6	0/6

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	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)
VomitingGastrointestinal disorders	0/5	0/5	1/5	0/5	2/6	0/6
PyrexiaGeneral disorders	0/5	0/5	1/5	0/5	2/6	0/6
AnaemiaBlood and lymphatic system disorders	0/5	0/5	1/5	0/5	0/6	0/6
TachycardiaCardiac disorders	0/5	0/5	1/5	0/5	0/6	0/6
DiarrhoeaGastrointestinal disorders	1/5	0/5	0/5	0/5	0/6	0/6
Faeces discolouredGastrointestinal disorders	0/5	1/5	0/5	0/5	0/6	0/6
Blood pressure systolic decreasedInvestigations	1/5	0/5	0/5	0/5	0/6	0/6
Blood pressure systolic increasedInvestigations	1/5	0/5	0/5	0/5	0/6	0/6
Haemoglobin decreasedInvestigations	1/5	0/5	0/5	0/5	1/6	0/6
Heart rate decreasedInvestigations	1/5	0/5	0/5	0/5	0/6	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	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
Mean	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
Sex: Female, Male(Participants)	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
Female	1	2	1	3	2	4	13
Male	4	3	4	2	4	2	19

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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
Hispanic or Latino	3	1	2	0	3	2	11
Not Hispanic or Latino	2	4	3	5	3	4	21
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	1	2	0	0	1	0	4
White	4	3	5	5	4	5	26
More than one race	0	0	0	0	1	1	2
Unknown or Not Reported	0	0	0	0	0	0	0

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 33710976 ↗

Study documents

Protocol and statistical analysis plan · Jun 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Dec 2018, 31 months.

Results were first posted in Dec 2019, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 1, 2016
First posted: Apr 25, 2016
StartActual: May 2, 2016
Primary completionActual: Dec 16, 2018
CompletionActual: Dec 21, 2018
Results first posted: Dec 20, 2019
Last update: Dec 20, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02750761
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 25, 2016
Start date: May 2, 2016
Primary completion: Dec 16, 2018
Completion: Dec 21, 2018
Results posted: Dec 20, 2019
Last update: Dec 20, 2019

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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