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Small Molecule

Effect of Venglustat in Patients With Renal Impairment

Phase 1
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 10
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Polycystic Kidney Disease
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
Secondary study objectives
Venglustat plasma pharmacokinetic (PK) parameter: AUClast
Venglustat plasma pharmacokinetic (PK) parameter: CL/F
Venglustat plasma pharmacokinetic (PK) parameter: Cmax
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VenglustatExperimental Treatment1 Intervention
Single dose of Venglustat is given, orally under fasting conditions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venglustat GZ/SAR402671
2018
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
527 Previous Clinical Trials
185,712 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,634 Total Patients Enrolled
~3 spots leftby Dec 2025
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