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CompletedNCT03369002Updated May 18, 2018

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

A Phase 1 interventional study of seladelpar in Hepatic Impairment, sponsored by Gilead Sciences. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic Impairment

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Keywords

  • Hepatic Impairment
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Normal

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

    Drug: seladelpar

  • Experimental
    Mild Impairment

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

    Drug: seladelpar

  • Experimental
    Moderate Impairment

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

    Drug: seladelpar

  • Experimental
    Severe Impairment

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

    Drug: seladelpar

Interventions

  • Drugseladelpar

    Oral single dose 10 mg

    Also known as: MBX-8025

05

What researchers measure

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 5 days

  2. Time to reach maximum concentration (Tmax)

    Time frame: 5 days

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

    Time frame: 5 days

  4. Elimination of half-life (t1/2)

    Time frame: 5 days

  5. Apparent terminal elimination rate constant (λz)

    Time frame: 5 days

  6. Total body clearance (CL/F)

    Time frame: 5 days

  7. Volume of distribution (Vz/F)

    Time frame: 5 days

06

Study locations

4 sites
  • DaVita Clinical Research
    Lakewood, Colorado 80228, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • DaVita Clinical Research
    Minneapolis, Minnesota 55404, United States
  • Vrg & Noccr
    Knoxville, Tennessee 37920, United States
07

Registry details

Key details

Study ID
NCT03369002
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Dec 11, 2017
Start date
Nov 27, 2017
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
May 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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