This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat. The purpose of this study is to assess the effect of mild, moderate, and severe hepatic impairment on PK, safety, and tolerability of venglustat compared with normal hepatic function in male and female participants aged 18 to 79 years. Study details include: * The total study duration per participant will be up to 42 days, including up to 21 days for screening and approximately 21 days from institutionalization to the end of study (EOS). * Institutionalization is mandatory until the activities on D5 have been completed. * Each participant will receive a single dose of venglustat. * For hepatically impaired participants there will be a screening visit, a multi-day institutionalization visit, and 7 site visits after D5 discharge, including the end of study (EOS) visit. * For healthy volunteers there will be a screening visit, a multi-day institutionalization visit and 3 site visits after D5 discharge, including the end of study (EOS) visit.
The duration of the study for a participant in any arm will be up to 42 days. The treatment and follow up periods will last for a combined total of approximately 20 days, while the screening period will be up to 3 weeks, but may be shorter on an individual basis. Screening period: up to 3 weeks (Days -21 to -2). Open-label treatment period with compulsory institutionalization (Days -1 to 5). Follow up period lasting until approximately day 20 ± 2 days post administration. This will include 7 additional site visits (including the EOS visit) for hepatically impaired groups. The group with normal hepatic function will only need to return D6 and D7 for study visit after institutionalization is completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Pharmaceutical form: tablet Route of administration: oral
Inland Empire Liver Foundation Site Number : 8400004
Rialto, California, United States
Clinical Pharmacology of Miami Site Number : 8400002
Miami, Florida, United States
Nucleus Network Site Number : 8400001
Saint Paul, Minnesota, United States
Volunteer Research Group-NOCCR Site Number : 8400003
Knoxville, Tennessee, United States
American Research Corporation Site Number : 8400005
San Antonio, Texas, United States
Investigational Site Number : 2760001
Kiel, Germany
Maximum venglustat plasma concentration observed (Cmax)
Time frame: Baseline to Day 20
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Time frame: Baseline to Day 20
Time to maximum venglustat plasma concentration (tmax)
Time frame: Baseline to Day 20
Number of participants with adverse event (AE), treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI)
Time frame: Baseline to Day 20
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