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

Completed Phase 1
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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 function * Group 2: Participants with moderate liver impairment * Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable) Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-04-01; most recent amendment 2026-04-29.
Status change: Recruiting → Completed 2026-02-27
Trial Details
NCT Number NCT06908954
Lead Sponsor Ipsen
Conditions Hepatic Impairment, Healthy
Enrollment 31 participants
Start Date 2025-03-14
Primary Completion 2026-02-06 (estimated)
Study Completion 2026-02-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-30