Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
- Registration Number
- NCT03369002
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief Summary
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Must have given written informed consent (signed and dated) and any authorizations required by local law.
- Willing to be confined to CRU for the entire duration required by the protocol.
- Male or female, between 18 and 80 years of age.
- Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
Exclusion Criteria
- Pregnant or lactating women.
- Treatment with another investigational drug or device within 30 days prior to study drug administration.
- Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- Inability to swallow medication.
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
- Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal seladelpar Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar Mild Impairment seladelpar Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar Moderate Impairment seladelpar Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar Severe Impairment seladelpar Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar
- Primary Outcome Measures
Name Time Method Apparent terminal elimination rate constant (λz) 5 days Area under of the curve (AUC0-t and AUC0-∞) 5 days Elimination of half-life (t1/2) 5 days Total body clearance (CL/F) 5 days Time to reach maximum concentration (Tmax) 5 days Volume of distribution (Vz/F) 5 days Maximum plasma concentration (Cmax) 5 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Vrg & Noccr
🇺🇸Knoxville, Tennessee, United States
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States