Effect of Venglustat in Patients With Renal Impairment

Phase 1

Completed

• Conditions: Healthy Volunteers; Polycystic Kidney, Autosomal Dominant
• Interventions: Drug: Venglustat GZ/SAR402671

• Registration Number: NCT03687554
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Study Start: 2018-10-05
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venglustat	Venglustat GZ/SAR402671	Single dose of Venglustat is given, orally under fasting conditions

Primary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)	Day 1 to Day 10	Venglustat area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Venglustat plasma pharmacokinetic (PK) parameter: AUClast	Day 1 to Day 10	Area under the plasma concentration versus time curve calculated from time zero to the real time tlast (AUClast)
Venglustat plasma pharmacokinetic (PK) parameter: t1/2eff	Day 1 to Day 10	Effective half-life (t1/2eff)
Venglustat urine pharmacokinetic (PK) parameter: fe(0-24)	Day 1 and Day 2	Fraction of dose excreted in urine from time 0 to time 24h after Venglustat administration
Venglustat urine pharmacokinetic (PK) parameter: CLR(0-24)	Day 1 and Day 2	Renal clearance of the drug determined in the 0-24h interval (CLR(0-24))
Venglustat plasma pharmacokinetic (PK) parameter: Rac,pred	Day 1 to Day 10	Predicted accumulation ratio (Rac,pred)
Venglustat plasma pharmacokinetic (PK) parameter: Cmax	Day 1	Maximum plasma concentration observed (Cmax)
Venglustat plasma pharmacokinetic (PK) parameter: Vss/F	Day 1 to Day 10	Apparent volume of distribution of Venglustat at steady state (Vss/F)
Venglustat urine pharmacokinetic (PK) parameter: Ae(0-24)	Day 1 and Day 2	Cumulated amount excreted in urine from time 0 to time 24h after Venglustat administration
Venglustat plasma pharmacokinetic (PK) parameter: unbound Cmax	Day 1 to Day 10	Maximum plasma concentration observed of unbound drug (unbound Cmax)
Venglustat plasma pharmacokinetic (PK) parameter: unbound AUC	Day 1 to Day 10	Change in unbound Venglustat area under the plasma concentration versus time curve (unbound AUC)
Venglustat plasma pharmacokinetic (PK) parameter: CL/F	Day 1 to Day 10	Apparent total body clearance of Venglustat from plasma (CL/F)
Venglustat plasma pharmacokinetic (PK) parameter: fu	Day 1 to Day 10	Fraction of unbound venglustat in plasma (fu)
Venglustat plasma pharmacokinetic (PK) parameter: t1/2z	Day 1 to Day 10	Terminal half-life associated with the terminal slope (t1/2z)

Trial Locations

Locations (1)

Investigational Site Number 8400001; 🇺🇸 Miami, Florida, United States