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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Pharmaceutical form: Hard Capsule Route of administration: Oral
Investigational Site Number 8400001
Miami, Florida, United States
Assessment of pharmacokinetic (PK) parameters of Venglustat: Area under the curve (AUC)
Venglustat area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: Cmax
Maximum plasma concentration observed (Cmax)
Time frame: Day 1
Venglustat plasma pharmacokinetic (PK) parameter: AUClast
Area under the plasma concentration versus time curve calculated from time zero to the real time tlast (AUClast)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: unbound Cmax
Maximum plasma concentration observed of unbound drug (unbound Cmax)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: unbound AUC
Change in unbound Venglustat area under the plasma concentration versus time curve (unbound AUC)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: CL/F
Apparent total body clearance of Venglustat from plasma (CL/F)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: Vss/F
Apparent volume of distribution of Venglustat at steady state (Vss/F)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: fu
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Fraction of unbound venglustat in plasma (fu)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: t1/2z
Terminal half-life associated with the terminal slope (t1/2z)
Time frame: Day 1 to Day 10
Venglustat plasma pharmacokinetic (PK) parameter: t1/2eff
Effective half-life (t1/2eff)
Time frame: Day 1 to Day 10
Venglustat urine pharmacokinetic (PK) parameter: Ae(0-24)
Cumulated amount excreted in urine from time 0 to time 24h after Venglustat administration
Time frame: Day 1 and Day 2
Venglustat urine pharmacokinetic (PK) parameter: fe(0-24)
Fraction of dose excreted in urine from time 0 to time 24h after Venglustat administration
Time frame: Day 1 and Day 2
Venglustat urine pharmacokinetic (PK) parameter: CLR(0-24)
Renal clearance of the drug determined in the 0-24h interval (CLR(0-24))
Time frame: Day 1 and Day 2
Venglustat plasma pharmacokinetic (PK) parameter: Rac,pred
Predicted accumulation ratio (Rac,pred)
Time frame: Day 1 to Day 10