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

An Open-Label, Single-Dose, Parallel-Group, Two-Part Study to Evaluate the Pharmacokinetics and Safety of Risdiplam in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Muscular Atrophy, Spinal

Interventions

Type	Name	Description
DRUG	Risdiplam	5 milligram (mg) oral dose administered in fasted state

Timeline

• Start date: 2019-05-16
• Primary completion: 2020-01-02
• Completion: 2020-01-02
• First posted: 2019-04-19
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study