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

Hepatic Impairment Clinical Trial

Official title:

A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369002
• Other study ID #: CB8025-11732
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2018
• Source: CymaBay Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• seladelpar
Oral single dose 10 mg

Locations

Country	Name	City	State
United States	Vrg & Noccr	Knoxville	Tennessee
United States	DaVita Clinical Research	Lakewood	Colorado
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CymaBay Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		5 days
Primary	Time to reach maximum concentration (Tmax)		5 days
Primary	Area under of the curve (AUC0-t and AUC0-8)		5 days
Primary	Elimination of half-life (t1/2)		5 days
Primary	Apparent terminal elimination rate constant (?z)		5 days
Primary	Total body clearance (CL/F)		5 days
Primary	Volume of distribution (Vz/F)		5 days