At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Risdiplamdrug
Likely dose
Risdiplam 5 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Risdiplam for Muscular Atrophy, Spinal. Completed, enrolled 26 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Atrophy, Spinal
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartMay 2019
Primary CompletionJan 2020
TodayJul 2026
First PostedApr 19, 2019
Enrollment StartMay 16, 2019
Primary CompletionJan 2, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.2 years ago
Interventions
Risdiplamdrug
5 milligram (mg) oral dose administered in fasted state