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

NCT ID: NCT03369002

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2018-05-15

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal

Child-Pugh Score: N/A

Subjects will receive a single 10 mg oral dose of seladelpar

Group Type: EXPERIMENTAL

seladelpar

Intervention Type: DRUG

Oral single dose 10 mg

Mild Impairment

Child-Pugh Score: A (5 to 6 points)

Subjects will receive a single 10 mg oral dose of seladelpar

Group Type: EXPERIMENTAL

seladelpar

Intervention Type: DRUG

Oral single dose 10 mg

Moderate Impairment

Child-Pugh Score: B (7 to 9 points)

Subjects will receive a single 10 mg oral dose of seladelpar

Group Type: EXPERIMENTAL

seladelpar

Intervention Type: DRUG

Oral single dose 10 mg

Severe Impairment

Child-Pugh Score: C (10 to 15 points)

Subjects will receive a single 10 mg oral dose of seladelpar

Group Type: EXPERIMENTAL

seladelpar

Intervention Type: DRUG

Oral single dose 10 mg

Interventions

seladelpar

Oral single dose 10 mg

Intervention Type: DRUG

Other Intervention Names

MBX-8025

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DaVita Clinical Research

Lakewood, Colorado, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States

Vrg & Noccr

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

CB8025-11732

Identifier Type: -

Identifier Source: org_study_id