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

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 14, 2025

Primary Completion Date

June 17, 2026

Study Completion Date

June 17, 2026

Conditions
Hepatic ImpairmentHealthy
Interventions
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).

Trial Locations (3)

32809

RECRUITING

Orlando Clinical Research Center, Orlando

33172

RECRUITING

ERG - Clinical Pharmacology of Miami, Miami

78215

RECRUITING

American Research Corporation/Texas Liver Institute, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY

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 | Biotech Hunter | Biotech Hunter