NCT02750761

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, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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).

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

• Gram-Positive Bacterial Infections

Interventions

Type	Name	Description
DRUG	Tedizolid Phosphate (IV)	200 mg/vial powder for injection
DRUG	Tedizolid Phosphate (oral suspension)	Powder for oral suspension 20 mg/mL following reconstitution

Timeline

• Start date: 2016-05-02
• Primary completion: 2018-12-16
• Completion: 2018-12-21
• First posted: 2016-04-25
• Last updated: 2019-12-20
• Results posted: 2019-12-20

Regulatory

• FDA-regulated drug study