drugset / Trial / NCT05765344
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2025-01-10
- Completion
- 2025-01-13
Publications
- Background Kumar P, Mercier RC, Nieves W, Pan D, Tseng S, Chee GM, et al. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 2 mg Once Daily for 6 Days in Participants With Moderate and Severe HI and in Matched Control Participants With Normal Hepatic Function. American Association for the Study of Liver Diseases (AASLD); 1154: 15 November 2024
- Background Parag Kumar, Wildaliz Nieves, David Pan, Steve Tseng, Yuejiao Jiang, Yehong Wang, Ann Qin, Teckla Akinyi, Renee-Claude Mercier. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 10 mg Once Daily for 6 Days in Participants With Moderate HI and in Matched Control Participants With Normal Hepatic Function. EASL - European Association for the Study of the Liver May 7-10, 2025 Amsterdam the Netherlands
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bulevirtide | Protein / enzyme biologic | 2 mg | Subcutaneous |
| Subject | Bulevirtide | Protein / enzyme biologic | 10 mg | Subcutaneous |
Indications
No indication recorded.