NCT03920865View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 16, 2019

Primary Completion Date

January 2, 2020

Study Completion Date

January 2, 2020

Conditions
Muscular Atrophy, Spinal
Interventions
DRUG

Risdiplam

5 milligram (mg) oral dose administered in fasted state

Trial Locations (3)

32809

Orlando Clinical Research Center, Orlando

33014

Clinical Pharmacology of Miami, Inc., Miami

78215

American Research Corporation Inc., San Antonio

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter