NCT00671814

Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701

Detailed description

This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TR-701	TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.
DRUG	linezolid	Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.
DRUG	placebo	Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.

Timeline

• Start date: 2008-01-06
• Primary completion: 2008-06-06
• Completion: 2008-06-06
• First posted: 2008-05-05
• Last updated: 2017-08-31

Locations

1 site across 1 country: United States