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NCT01817985 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01817985: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01817985 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01817985, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
Primary Outcome
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Interventions
- DRUG GS-5816
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01817985 record still lists
NCT01817985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which GS-5816 is the first listed.
NCT01817985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01817985 about?
NCT01817985 is a clinical study titled "A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment". This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
What is the current status of trial NCT01817985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-03. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01817985?
The interventions under investigation include: GS-5816 (DRUG).
Who is sponsoring clinical trial NCT01817985?
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 NCT01817985's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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