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

About the trial

Sponsor

Ipsen

Tested

Palovarotene (drug), Palovarotene (drug), Palovarotene (drug)

Dates

Started 2025-03-14; completion 2026-02-06

Results posted

Not yet

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 sampl…

From ClinicalTrials.gov, last updated 2026-04-30. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ipsen Bioscience Inc. reported $675,241 in research payments for this study in 2025 (57 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.