NCT01461460

A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.

Detailed description

To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	TR-701 FA 1200 mg	6 tablet of T-701 FA
DRUG	Moxifloxacin 400 mg	1 tablet 400 mg Moxifloxacin
DRUG	TR-701 FA 200 mg plus Placebo	1 tablet of TR-701 FA with 5 tablet placebo
DRUG	Placebo	6 placebo tablets

Timeline

• Start date: 2011-11-28
• Primary completion: 2011-12-23
• Completion: 2011-12-23
• First posted: 2011-10-28
• Last updated: 2018-12-05

Locations

1 site across 1 country: United States