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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: seladelpar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Impairment