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NCT05765344 · ClinicalTrials.gov registry record · Phase 1
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
A Phase 1 study of Healthy and Hepatic Impairment, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 6
- Study locations
NCT05765344: Completed Phase 1 study of Healthy and Hepatic Impairment, sponsored by Gilead Sciences.
NCT05765344 is a Phase 1 study of Healthy and Hepatic Impairment that has completed, run by Gilead Sciences. The registered enrollment target is 74 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05765344, a Phase 1 study of Healthy and Hepatic Impairment, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 6
- Study locations
Study Summary
The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function.
Primary Outcome
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
Conditions Studied
Interventions
- DRUG Bulevirtide
Study Locations (6)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
- University of Miami - Miami
- Orlando Clinical Research Center - Orlando
Texas
- Texas Liver Institute - San Antonio
- Pinnacle Clinical Research LLC - San Antonio
California
- Orange County Research Center - Lake Forest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2025-01-13 |
| Phase | Phase 1 |
What the finished NCT05765344 record still lists
NCT05765344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Bulevirtide is the first listed.
NCT05765344 lists 6 locations in 3 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT05765344 about?
NCT05765344 is a clinical study titled "Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function". The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (...
What is the current status of trial NCT05765344?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-03-15. Estimated completion is 2025-01-13.
What conditions does trial NCT05765344 study?
This clinical trial studies the following conditions: Healthy, Hepatic Impairment.
What interventions are being tested in trial NCT05765344?
The interventions under investigation include: Bulevirtide (DRUG).
Who is sponsoring clinical trial NCT05765344?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05765344 being conducted?
This trial has 6 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05765344's enrollment target sits among peer trials
74 311th of 1090 higher than 779 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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