NCT05765344

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

A Phase 1, Open-label, Parallel-group, Multiple-dose Study to Evaluate the Pharmacokinetics of Bulevirtide in Participants With Normal and Impaired Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Bulevirtide	2 mg administered via subcutaneous injections.
DRUG	Bulevirtide	10 mg administered via subcutaneous injections.

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-01-10
• Completion: 2025-01-13
• First posted: 2023-03-13
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study