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NCT03988907 · ClinicalTrials.gov registry record · Phase 1
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03988907: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03988907 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03988907, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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.
Primary Outcome
In Part 2 of the study, all study participants received a single oral dose of 2 mg midazolam on Day 1. On Day 3, the 14-day once daily (QD) treatment period with risdiplam began, with single dose administration of 2 mg midazolam again on Day 15 (1 hour after the thirteenth dose of risdiplam). The following treatment sequence was used in Part 2 of the study: Day 1: 2 mg midazolam; Days 3 to 14: 8 mg risdiplam QD; Day 15: 2 mg midazolam and 8 mg risdiplam QD; Day 16: 8 mg risdiplam QD. Blood sampl
Interventions
- DRUG Midazolam
- DRUG Risdiplam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2019-09-29 |
| Phase | Phase 1 |
What the finished NCT03988907 record still lists
NCT03988907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT03988907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03988907 about?
NCT03988907 is a clinical study titled "A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants". 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 f...
What is the current status of trial NCT03988907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-06-18. Estimated completion is 2019-09-29.
What interventions are being tested in trial NCT03988907?
The interventions under investigation include: Midazolam (DRUG), Risdiplam (DRUG).
Who is sponsoring clinical trial NCT03988907?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03988907's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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