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

CymaBay Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: seladelpar

Study type: Interventional

Funder types: Industry

Identifiers

NCT03369002

CB8025-11732

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Normal

Experimental group

Description:

Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar

Treatment:

Drug: seladelpar

Mild Impairment

Experimental group

Description:

Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar

Treatment:

Drug: seladelpar

Moderate Impairment

Experimental group

Description:

Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar

Treatment:

Drug: seladelpar

Severe Impairment

Experimental group

Description:

Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar

Treatment:

Drug: seladelpar