NCT06908954

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

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 Participants With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Palovarotene	A single dose of maximum 10 mg of palovarotene will be administered orally on Day 1 to healthy control participants with normal hepatic function
DRUG	Palovarotene	A single 10 mg dose of palovarotene will be administered orally on Day 1 to Moderate hepatic impaired participants (Child-Pugh class B)
DRUG	Palovarotene	A single 10 mg dose of either 5 mg or 10 mg of palovarotene will be administered orally on Day 1 to Severe hepatic impaired participants (Child-Pugh class C).

Timeline

• Start date: 2025-03-14
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2025-04-03
• Last updated: 2026-04-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study