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NCT01623401 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-Label, 10 Day Safety Study
A Phase 1 study of Healthy Subjects, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01623401: Completed Phase 1 study of Healthy Subjects, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01623401 is a Phase 1 study of Healthy Subjects that has completed, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 72 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623401, a Phase 1 study of Healthy Subjects, has completed, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments.
Primary Outcome
The primary objective is to determine the safety of oral 200 mg TR-701 free acid (FA) administered once daily for 10 days in healthy adults. Safety outcome measures include the number and proportion of participants with adverse events, changes in vital signs and ECG, and evaluation of physical examination changes including neurologic and ophthalmologic exams.
Conditions Studied
Interventions
- DRUG TR-701 FA
Study Locations (1)
Texas
- Trius Investigator Site 001 - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-05-17 |
| Est. Completion | 2012-08-24 |
| Phase | Phase 1 |
Sponsor
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 total trials
What the finished NCT01623401 record still lists
NCT01623401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which TR-701 FA is the first listed.
NCT01623401 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01623401 about?
NCT01623401 is a clinical study titled "A Phase 1, Open-Label, 10 Day Safety Study". This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments.
What is the current status of trial NCT01623401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2012-05-17. Estimated completion is 2012-08-24.
What conditions does trial NCT01623401 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01623401?
The interventions under investigation include: TR-701 FA (DRUG).
Who is sponsoring clinical trial NCT01623401?
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.
Where is trial NCT01623401 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01623401's enrollment target sits among peer trials
72 18th of 69 higher than 52 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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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