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NCT06418607 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
A Phase 1 study of Healthy Volunteers, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 2
- Study locations
NCT06418607: Completed Phase 1 study of Healthy Volunteers, sponsored by Sanofi.
NCT06418607 is a Phase 1 study of Healthy Volunteers that has completed, run by Sanofi. The registered enrollment target is 65 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06418607, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions. Also, to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole) under fasting conditions in healthy adult participants. The maximum duration for participants from screening is up to 47 days.
Conditions Studied
Interventions
- DRUG Venglustat
Study Locations (2)
Florida
- Clinical Pharmacology of Miami Site Number : 8400001 - Miami
Minnesota
- Prism Research Site Number : 8400002 - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-06-23 |
| Est. Completion | 2020-07-13 |
| Phase | Phase 1 |
What the finished NCT06418607 record still lists
NCT06418607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Venglustat is the first listed.
NCT06418607 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06418607 about?
NCT06418607 is a clinical study titled "A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants". The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions. Also, to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole) under fasting conditions...
What is the current status of trial NCT06418607?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2020-06-23. Estimated completion is 2020-07-13.
What conditions does trial NCT06418607 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06418607?
The interventions under investigation include: Venglustat (DRUG).
Who is sponsoring clinical trial NCT06418607?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06418607 being conducted?
This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06418607's enrollment target sits among peer trials
65 104th of 283 higher than 179 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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