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
Overview
- Phase
- Phase 1
- Intervention
- Venglustat GZ/SAR402671
- Conditions
- Healthy Volunteers
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Venglustat
Single dose of Venglustat is given, orally under fasting conditions
Intervention: Venglustat GZ/SAR402671
Outcomes
Primary Outcomes
Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
Time Frame: Day 1 to Day 10
Venglustat area under the plasma concentration versus time curve (AUC)
Secondary Outcomes
- Venglustat plasma pharmacokinetic (PK) parameter: AUClast(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: t1/2eff(Day 1 to Day 10)
- Venglustat urine pharmacokinetic (PK) parameter: fe(0-24)(Day 1 and Day 2)
- Venglustat urine pharmacokinetic (PK) parameter: CLR(0-24)(Day 1 and Day 2)
- Venglustat plasma pharmacokinetic (PK) parameter: Rac,pred(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: Cmax(Day 1)
- Venglustat plasma pharmacokinetic (PK) parameter: Vss/F(Day 1 to Day 10)
- Venglustat urine pharmacokinetic (PK) parameter: Ae(0-24)(Day 1 and Day 2)
- Venglustat plasma pharmacokinetic (PK) parameter: unbound Cmax(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: unbound AUC(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: CL/F(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: fu(Day 1 to Day 10)
- Venglustat plasma pharmacokinetic (PK) parameter: t1/2z(Day 1 to Day 10)