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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03369002

Enrollment

Registered

2017-12-11

Start date

2017-11-27

Completion date

2018-05-15

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment

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.

Interventions

DRUGseladelpar

Oral single dose 10 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Time to reach maximum concentration (Tmax)	5 days
Maximum plasma concentration (Cmax)	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026