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

Sponsor
CymaBay Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03369002
Collaborator
(none)
32
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 27, 2017
Actual Primary Completion Date :
May 15, 2018
Actual Study Completion Date :
May 15, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum plasma concentration (Cmax) [5 days]

    2. Time to reach maximum concentration (Tmax) [5 days]

    3. Area under of the curve (AUC0-t and AUC0-∞) [5 days]

    4. Elimination of half-life (t1/2) [5 days]

    5. Apparent terminal elimination rate constant (λz) [5 days]

    6. Total body clearance (CL/F) [5 days]

    7. Volume of distribution (Vz/F) [5 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DaVita Clinical Research Lakewood Colorado United States 80228
    2 Orlando Clinical Research Center Orlando Florida United States 32809
    3 DaVita Clinical Research Minneapolis Minnesota United States 55404
    4 Vrg & Noccr Knoxville Tennessee United States 37920

    Sponsors and Collaborators

    • CymaBay Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CymaBay Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03369002
    Other Study ID Numbers:
    • CB8025-11732
    First Posted:
    Dec 11, 2017
    Last Update Posted:
    May 18, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CymaBay Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2018