drugset / Trial / NCT04993157
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage adjustment for FIA586 is necessary in patients with advanced liver fibrosis who have mild to moderate HI.
Timeline
- Start
- 2021-12-10
- Primary completion
- 2022-06-28
- Completion
- 2022-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FIA586 | Unknown | — | Oral |
Indications
No indication recorded.