NCT05760300

A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function

A Phase 1 Open-Label, Parallel-Design, Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide in Participants With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Bulevirtide (BLV)	Administered via subcutaneous (SC) injections

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-07-18
• Completion: 2024-07-23
• First posted: 2023-03-08
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study