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OpenTrials
Completed

NCT Number: NCT03369002

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

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.

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Key information

Conditions

Hepatic Impairment

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research, Lakewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seladelpar

Drug

Oral single dose 10 mg

Other names: MBX-8025

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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2017
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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