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NCT01046058 · ClinicalTrials.gov registry record · Phase 1
TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
A Phase 1 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT01046058: Completed Phase 1 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT01046058 is a Phase 1 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01046058, a Phase 1 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolerability of TMC435 in participants with hepatic impairment will be determined. The results of this study will guide dose recommendations for TMC435 in patients with impaired liver function.
Interventions
- DRUG TMC435
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01046058 record still lists
NCT01046058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which TMC435 is the first listed.
NCT01046058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01046058 about?
NCT01046058 is a clinical study titled "TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435". The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolera...
What is the current status of trial NCT01046058?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01046058?
The interventions under investigation include: TMC435 (DRUG).
Who is sponsoring clinical trial NCT01046058?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01046058's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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