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NCT02891408 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT02891408: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT02891408 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891408, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK of fenofibrate in adults with normal hepatic function and mild hepatic impairment.
Primary Outcome
AUClast is defined as the concentration of drug from time zero to the last observable concentration. The PK of fenofibric acid was evaluated in participants with mild hepatic impairment and matched participants with normal hepatic function (Cohort 4).
Interventions
- DRUG Fenofibrate
- DRUG Firsocostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2016-09-23 |
| Est. Completion | 2019-05-13 |
| Phase | Phase 1 |
What the finished NCT02891408 record still lists
NCT02891408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Fenofibrate is the first listed.
NCT02891408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891408 about?
NCT02891408 is a clinical study titled "Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function". The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK of fenofibrate in adults with normal hepatic function and mild hepatic...
What is the current status of trial NCT02891408?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2016-09-23. Estimated completion is 2019-05-13.
What interventions are being tested in trial NCT02891408?
The interventions under investigation include: Fenofibrate (DRUG), Firsocostat (DRUG).
Who is sponsoring clinical trial NCT02891408?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02891408's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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