NCT03687554

Effect of Venglustat in Patients With Renal Impairment

A Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 41 days, including a 21-day screening period, a 1-day treatment period, followed by a 9-day period of plasma sampling for assessment of primary endpoints.

Conditions

• Healthy Volunteers
• Polycystic Kidney, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	Venglustat GZ/SAR402671	Pharmaceutical form: Hard Capsule Route of administration: Oral

Timeline

• Start date: 2018-10-05
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2018-09-27
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study