drugset / Trial / NCT05393076
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function. All participants in both cohorts (moderate hepatic impairment and matched healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and safety of linerixibat.
Timeline
- Start
- 2022-07-19
- Primary completion
- 2022-12-06
- Completion
- 2022-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linerixibat | Small molecule | — | — |
Indications
No indication recorded.