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First received: March 24, 2025

Clinical Trial: A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Hepatic Impairment

Study Type: INTERVENTIONAL


Official Title: A Phase I, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Palovarotene in Male and Female Participants With Moderate and Severe Hepatic Impairment and Matched Partici

Brief Summary: The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function.The study will also assess the safety and tolerability of the single dose of palovarotene.Participants will be enrolled in stages and divided into three groups based on their liver function:Group 1: Healthy participants with normal liver…

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