drugset / Trial / 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)

NCT02750761

Phase 1 Completed 32 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2016-05-02
Primary completion
2018-12-16
Completion
2018-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tedizolid Phosphate Small molecule 3 mg/kg Intravenous
Subject Tedizolid Phosphate Small molecule 4 mg/kg Intravenous
Subject Tedizolid Phosphate Small molecule 5 mg/kg Intravenous
Subject Tedizolid Phosphate Small molecule 6 mg/kg Intravenous