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NCT01431833 · ClinicalTrials.gov registry record · Phase 1
A PK and Safety Study in Subjects With Hepatic Impairment
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
- 32
- Enrollment target
NCT01431833: Completed Phase 1 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01431833 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 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431833, 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
- 32 participants
- Enrollment target
Study Summary
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.
Primary Outcome
PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.
Interventions
- DRUG TR-701 FA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
Sponsor
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 total trials
What the finished NCT01431833 record still lists
NCT01431833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which TR-701 FA is the first listed.
NCT01431833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431833 about?
NCT01431833 is a clinical study titled "A PK and Safety Study in Subjects With Hepatic Impairment". Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.
What is the current status of trial NCT01431833?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-08. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01431833?
The interventions under investigation include: TR-701 FA (DRUG).
Who is sponsoring clinical trial NCT01431833?
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 NCT01431833's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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