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

NCT03369002 | Completed Phase 1 FDA Drug

• 1 other identifier: CB8025-11732
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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

Keywords

Hepatic Impairment

Outcome Measures

Primary Outcomes (7)

• Maximum plasma concentration (Cmax)

  5 days

• Time to reach maximum concentration (Tmax)

  5 days

• Area under of the curve (AUC0-t and AUC0-∞)

  5 days

• Elimination of half-life (t1/2)

  5 days

• Apparent terminal elimination rate constant (λz)

  5 days

• Total body clearance (CL/F)

  5 days

• Volume of distribution (Vz/F)

  5 days

Study Arms (4)

Normal

EXPERIMENTAL

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

Drug: seladelpar

Mild Impairment

EXPERIMENTAL

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

Drug: seladelpar

Moderate Impairment

EXPERIMENTAL

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

Drug: seladelpar

Severe Impairment

EXPERIMENTAL

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

Drug: seladelpar

Interventions

seladelpar DRUG

Oral single dose 10 mg

Also known as: MBX-8025

Mild Impairment; Moderate Impairment; Normal; Severe Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (4)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Vrg & Noccr

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

seladelpar; (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 11, 2017
• Study Start: November 27, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (4)