A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
- Registration Number
- NCT02536937
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat.
Secondary Objective:
To assess the tolerability of eliglustat tartrate 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
The total study duration from screening period is approximately 31 days. In stage 1, only subjects with severe renal impairment and normal renal function will be enrolled. Subjects with mild and moderate renal impairment may be enrolled in stage 2 if the results in subjects with severe renal impairment show a substantial effect of reduced renal function on pharmacokinetics.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GZ385660 (healthy subjects) eliglustat Single dose of eliglustat tartrate will be given under fed conditions GZ385660 (subjects with mild renal impairment) eliglustat Single dose of eliglustat tartrate will be given under fed conditions GZ385660 (subjects with moderate renal impairment) eliglustat Single dose of eliglustat tartrate will be given under fed conditions GZ385660 (subjects with severe renal impairment) eliglustat Single dose of eliglustat tartrate will be given under fed conditions
- Primary Outcome Measures
Name Time Method - Assessment of PK parameter: Maximum plasma concentration observed (Cmax) 3 days - Assessment of PK parameter: Area under the plasma concentration (AUC) 3 days
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter: Apparent total body clearance (CL/F) 3 days Assessment of PK parameter: Area under the plasma concentration versus time curve (AUClast) 3 days Assessment of PK parameter: Apparent volume of distribution during the terminal phase (Vz/F) 3 days Assessment of PK parameter: Predicted accumulation ratio (Rac,pred) 3 days Assessment of PK parameter: Terminal half-life (t1/2z) 3 days Number of adverse events Up to 10 days
Trial Locations
- Locations (3)
Investigational Site Number 840004
🇺🇸Miami, Florida, United States
Investigational Site Number 840001
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 840002
🇺🇸St. Paul, Minnesota, United States