A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
NCT01461460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2018-12-05
Summary
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Conditions
- Healthy Volunteer
Interventions
- 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
-
6 placebo tablets
Sponsors & Collaborators
-
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
lead INDUSTRY
Principal Investigators
-
Philippe G Prokocimer, MD · Trius Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-11-28
- Primary Completion
- 2011-12-23
- Completion
- 2011-12-23
Countries
- United States
Study Locations
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