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NCT03920865 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Muscular Atrophy, Spinal, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT03920865: Completed Phase 1 study of Muscular Atrophy, Spinal, sponsored by Hoffmann-La Roche.
NCT03920865 is a Phase 1 study of Muscular Atrophy, Spinal that has completed, run by Hoffmann-La Roche. The registered enrollment target is 26 participants, below the 74-participant average among 15 other Muscular Atrophy, Spinal trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03920865, a Phase 1 study of Muscular Atrophy, Spinal, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Risdiplam
Study Locations (3)
Florida
- Clinical Pharmacology of Miami, Inc. - Miami
- Orlando Clinical Research Center - Orlando
Texas
- American Research Corporation Inc. - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2020-01-02 |
| Phase | Phase 1 |
What the finished NCT03920865 record still lists
NCT03920865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 74-participant average among 15 other Muscular Atrophy, Spinal trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Muscular Atrophy, Spinal appearing as the primary indexed condition, and to 1 intervention - of which Risdiplam is the first listed.
NCT03920865 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT03920865 about?
NCT03920865 is a clinical study titled "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". 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.
What is the current status of trial NCT03920865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-05-16. Estimated completion is 2020-01-02.
What conditions does trial NCT03920865 study?
This clinical trial studies the following conditions: Muscular Atrophy, Spinal.
What interventions are being tested in trial NCT03920865?
The interventions under investigation include: Risdiplam (DRUG).
Who is sponsoring clinical trial NCT03920865?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03920865 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Muscular Atrophy, Spinal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03920865's enrollment target sits among peer trials
26 12th of 15 higher than 3 of 15 other Muscular Atrophy, Spinal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscular Atrophy, Spinal 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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