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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03687554
The ClinicalTrials.gov registry entry for NCT03687554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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