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NCT05718258 · ClinicalTrials.gov registry record · Phase 1
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT05718258: Completed Phase 1 study, sponsored by Sanofi.
NCT05718258 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05718258, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat. The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety, and tolerability of venglustat compared with normal hepatic function in male and female participants aged 18 to 79 years. Study details include: * The total study duration per participant will be up to 42 days, including up to 21 days for screening and approximately 21 days from institutionalization to the end of study (EOS). * Institutionalization is mandatory until the activities on D5 have been completed. * Each participant will receive a single dose of venglustat. * For hepatically impaired participants there will be a screening visit, a multi-day institutionalization visit, and 7 site visits after D5 discharge, including the end of study (EOS) visit. * For healthy volunteers there will be a screening visit, a multi-day institutionalization visit and 3 site visits after D5 discharge, including the end of study (EOS) visit.
Interventions
- DRUG Venglustat (GZ402671)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 1 |
What the finished NCT05718258 record still lists
NCT05718258 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Venglustat (GZ402671) is the first listed.
NCT05718258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05718258 about?
NCT05718258 is a clinical study titled "A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function". This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat. The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety...
What is the current status of trial NCT05718258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2023-01-18. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT05718258?
The interventions under investigation include: Venglustat (GZ402671) (DRUG).
Who is sponsoring clinical trial NCT05718258?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05718258's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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