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NCT02120547 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
A Phase 1 study, sponsored by Tobira Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02120547: Completed Phase 1 study, sponsored by Tobira Therapeutics.
NCT02120547 is a Phase 1 study that has completed, run by Tobira Therapeutics. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02120547, a Phase 1 study, has completed, sponsored by Tobira Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.
Primary Outcome
Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.
Interventions
- DRUG Cenicriviroc in mild liver impaired
- DRUG Cenicriviroc in moderate liver impaired
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02120547 record still lists
NCT02120547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Cenicriviroc in mild liver impaired is the first listed.
NCT02120547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02120547 about?
NCT02120547 is a clinical study titled "Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment". To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potentia...
What is the current status of trial NCT02120547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02120547?
The interventions under investigation include: Cenicriviroc in mild liver impaired (DRUG), Cenicriviroc in moderate liver impaired (DRUG).
Who is sponsoring clinical trial NCT02120547?
This trial is sponsored by Tobira Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02120547's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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