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A Phase 1, Open-Label, 10 Day Safety Study
NCT01623401 · View on ClinicalTrials.gov ↗
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.
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)1 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623401
The ClinicalTrials.gov registry entry for NCT01623401 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01623401 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01623401?
The interventions under investigation include: TR-701 FA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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