NCT01156077

Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.

Conditions

• Bacterial Infection

Interventions

Type	Name	Description
DRUG	TR-701 FA	Oral TR-701 FA 200 mg will be given as a single oral dose
DRUG	TR-701 FA	TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

Timeline

• Start date: 2010-06-02
• Primary completion: 2011-09-24
• Completion: 2011-09-24
• First posted: 2010-07-02
• Last updated: 2018-12-07