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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |