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

NCT03920865

Phase 1 Completed 26 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Risdiplam Small molecule 5 mg Oral