At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Risdiplam +1 moredrug
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.
A Phase I, 2-Part, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Risdiplam and the Effect of Risdiplam on the Pharmacokinetics of Midazolam Following Oral Administration in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Risdiplam and Midazolam for Spinal Muscular Atrophy. Completed, enrolled 35 participants across 1 site.
Detailed Summary
This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of midazolam (Part 2) following oral administration in healthy adult male and female participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJun 2019
Primary CompletionSep 2019
TodayJul 2026
First PostedJun 18, 2019
Enrollment StartJun 18, 2019
Primary CompletionSep 29, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.0 years ago
Interventions
Risdiplamdrug
Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results
Midazolamdrug
single dose administration of 2 mg midazolam