Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

• Status: Completed
• Trial end date: 2018-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CymaBay Therapeutics, Inc.
• Treatments: Seladelpar

Criteria

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.