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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03988907
The ClinicalTrials.gov registry entry for NCT03988907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT03988907 reports 0 study locations.
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.
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