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NCT01461460 · ClinicalTrials.gov registry record · Phase 1
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
A Phase 1 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01461460: Completed Phase 1 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01461460 is a Phase 1 study that has completed, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461460, a Phase 1 study, has completed, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Primary Outcome
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
Interventions
- DRUG Placebo
- DRUG Moxifloxacin 400 mg
- DRUG TR-701 FA 1200 mg
- DRUG TR-701 FA 200 mg plus Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-11-28 |
| Est. Completion | 2011-12-23 |
| Phase | Phase 1 |
Sponsor
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 total trials
What the finished NCT01461460 record still lists
NCT01461460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01461460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461460 about?
NCT01461460 is a clinical study titled "A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects". The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
What is the current status of trial NCT01461460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-11-28. Estimated completion is 2011-12-23.
What interventions are being tested in trial NCT01461460?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin 400 mg (DRUG), TR-701 FA 1200 mg (DRUG), TR-701 FA 200 mg plus Placebo (DRUG).
Who is sponsoring clinical trial NCT01461460?
This trial is sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461460's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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