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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: seladelpar

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • DaVita Clinical Research
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Vrg & Noccr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal; Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar	Drug: seladelpar; Oral single dose 10 mg; Other Names: MBX-8025
Experimental: Mild Impairment; Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar	Drug: seladelpar; Oral single dose 10 mg; Other Names: MBX-8025
Experimental: Moderate Impairment; Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar	Drug: seladelpar; Oral single dose 10 mg; Other Names: MBX-8025
Experimental: Severe Impairment; Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar	Drug: seladelpar; Oral single dose 10 mg; Other Names: MBX-8025

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CymaBay Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Hepatic Impairment
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Seladelpar
• Other Study ID Numbers: CB8025-11732

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No