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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03920865
The ClinicalTrials.gov registry entry for NCT03920865 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 74-participant average among 15 other Muscular Atrophy, Spinal trials with a reported enrollment target (65% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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