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Effect of Venglustat in Patients With Renal Impairment

NCT03687554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-25

No results posted yet for this 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

  • Healthy Volunteers
  • Polycystic Kidney, Autosomal Dominant

Interventions

DRUG

Venglustat GZ/SAR402671

Pharmaceutical form: Hard Capsule Route of administration: Oral

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2019-02-27
Completion
2019-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687554 on ClinicalTrials.gov