drugset / Trial / NCT03920865
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy participants with normal hepatic function.
Timeline
- Start
- 2019-05-16
- Primary completion
- 2020-01-02
- Completion
- 2020-01-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risdiplam | Small molecule | 5 mg | Oral |