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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 is a Phase 1 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01046058
The ClinicalTrials.gov registry entry for NCT01046058 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TMC435 is the first listed.
NCT01046058 reports 0 study locations.
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.
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