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NCT03687554 · ClinicalTrials.gov registry record · Phase 1
Effect of Venglustat in Patients With Renal Impairment
A Phase 1 study of Healthy Volunteers and Polycystic Kidney, Autosomal Dominant, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03687554: Completed Phase 1 study of Healthy Volunteers and Polycystic Kidney, Autosomal Dominant, sponsored by Genzyme, a Sanofi Company.
NCT03687554 is a Phase 1 study of Healthy Volunteers and Polycystic Kidney, Autosomal Dominant that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03687554, a Phase 1 study of Healthy Volunteers and Polycystic Kidney, Autosomal Dominant, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics (PK) of Venglustat following a single dose. Secondary Objective: To assess the tolerability of Venglustat given as a single dose in subjects with mild, moderate and severe renal impairment in comparison with matched subjects with normal renal function.
Primary Outcome
Venglustat area under the plasma concentration versus time curve (AUC)
Conditions Studied
Interventions
- DRUG Venglustat GZ/SAR402671
Study Locations (1)
Florida
- Investigational Site Number 8400001 - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-10-05 |
| Est. Completion | 2019-02-27 |
| Phase | Phase 1 |
What the finished NCT03687554 record still lists
NCT03687554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Venglustat GZ/SAR402671 is the first listed.
NCT03687554 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03687554 about?
NCT03687554 is a clinical study titled "Effect of Venglustat in Patients With Renal Impairment". Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics (PK) of Venglustat following a single dose. Secondary Objective: To assess the tolerability of Venglustat given as a single dose in subjects with mild, moderate and severe renal impairment...
What is the current status of trial NCT03687554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-10-05. Estimated completion is 2019-02-27.
What conditions does trial NCT03687554 study?
This clinical trial studies the following conditions: Healthy Volunteers, Polycystic Kidney, Autosomal Dominant.
What interventions are being tested in trial NCT03687554?
The interventions under investigation include: Venglustat GZ/SAR402671 (DRUG).
Who is sponsoring clinical trial NCT03687554?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03687554 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03687554's enrollment target sits among peer trials
24 204th of 283 higher than 66 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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