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

Last updated: May 27, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Palovarotene

Clinical Study ID

NCT06908954
CLIN-60120-458
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants must be 18 to 70 years of age (inclusive) at the timeof signing informed consent.

  • Body weight at least 60.0 kg with body mass index (BMI) within the range of 18.0 and 36.0 kg/m² (inclusive), at screening. BMI of >36.0 to ≤37.0 may be eligible ifparticipant has ascites scoring 3 points on the C-P criteria.

  • Contraceptive use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical trials

  • Clinical diagnosis of chronic hepatic disease (stable for more than 3 months) with adocumented history of underlying hepatic insufficiency and no acute episodes ofillness within 30 days prior to Day -1 (admission) and no significant change indisease status (i.e. up to 1 point in the C-P classification) from screening to Day -1.

  • A stable medication regimen, defined as not starting new therapy(ies) or significantchanging dosage(s) within 30 days prior to dosing.

Exclusion

Exclusion Criteria:

  • Presence or significant history of cardiovascular, respiratory, hepatic (except forthe hepatic impairment for those concerned), renal, gastrointestinal, biliary,mucocutaneous, endocrinological, haematological or neurological disorders capable ofsignificantly altering the absorption, metabolism, or elimination of drugs,constituting a risk when taking the study intervention, or interfering with theinterpretation of data.

  • Lymphoma, leukaemia or any malignancy within the past 5 years except for basal cellor squamous epithelial carcinomas of the skin that have been resected with noevidence of metastatic disease for 3 years.

  • Breast cancer within the past 10 years.

  • Use of any medications (prescription or over the counter), herbal tea, energy drinks (including natural stimulants), herbal products (e.g. St. John's wort, garlic, milkthistle) or supplements/supratherapeutic doses of vitamins within 14 days prior toDay 1 and through discharge, apart from those approved by the investigator and thesponsor's medical monitor. Those with hepatic impairment may take concomitantmedications

  • Use of any medications that are moderate or strong inhibitors or inducers of CYP3A4

  • Donation or loss (excluding volume drawn at screening or during menses) of more than 250 mL of blood or blood product within 3 months prior to screening. In addition,plan of blood donation within 8 weeks after the last PK sampling.

  • Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 monthsprior to the dose of study intervention.

  • Positive hepatitis C antibody test result at screening or within 3 months prior tothe dose of study intervention. Note: Participants with positive hepatitis Cantibody due to prior resolved disease can be enrolled if a confirmatory negativehepatitis C ribonucleic acid (RNA) test is obtained.

  • Positive hepatitis C RNA test result at screening or within 3 months prior to thedose of study intervention. Note: Test is optional and participants with negativehepatitis C antibody test are not required to also undergo hepatitis C RNA testing.

  • Sensitivity to the study intervention, or components thereof (including inactiveingredients), or drug or other allergy that, in the opinion of the investigator (ormedical monitor), contraindicates participation in the study

  • Evidence of relevant active disease at screening, including gastroenterological (other than hepatic cirrhosis), cardiac (e.g. myocardial infarction in the pastyear, angina or congestive heart failure), renal, respiratory, haematological,neuropsychiatric or neoplastic (basal or squamous cell skin cancer is acceptable)disease.

  • Acute hepatitis B (positive for HBsAg) or acute hepatitis C (positive foranti-hepatitis C virus (HCV) for a duration of less than 6 months). Note:Participants with chronic HCV (positive for HCV RNA or anti-HCV for more than 6months) are eligible for enrolment, if stable, as assessed by the investigator.

  • Primary sclerosing cholangitis or preliminary diagnosed biliary obstruction atscreening.

  • Current or chronic history of liver disease. This includes (but is not limited tohepatitis virus infections), drug- or alcohol-related liver disease, non-alcoholicsteatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis,or any other liver disease considered clinically significant by the investigator.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Palovarotene
Phase: 1
Study Start date:
March 14, 2025
Estimated Completion Date:
June 17, 2026

Connect with a study center

  • McGill University Health Centre - The Neuro

    Montréal,
    Canada

    Site Not Available

  • CARe Clinic

    Red Deer,
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia,
    Canada

    Site Not Available

  • Neurologie Brno s.r.o.

    Brno,
    Czechia

    Site Not Available

  • Pratia Brno s.r.o.

    Brno,
    Czechia

    Active - Recruiting

  • NEUROHK s.r.o.

    Choceň,
    Czechia

    Site Not Available

  • Nemocnice Jihlava, p.o.

    Jihlava,
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Axon Clinical, s.r.o.

    Praha,
    Czechia

    Active - Recruiting

  • DADO MEDICAL s.r.o.

    Praha,
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Praha,
    Czechia

    Active - Recruiting

  • Institut neuropsychiatricke pece

    Praha,
    Czechia

    Active - Recruiting

  • CHRU d'Amiens

    Amiens,
    France

    Site Not Available

  • CHU Nimes - Hôpital Caremeau

    Nîmes,
    France

    Site Not Available

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal

    Paris,
    France

    Site Not Available

  • Ltd "Health"

    Batumi,
    Georgia

    Site Not Available

  • "Pineo Medical Ecosystem" LTD

    Tbilisi,
    Georgia

    Site Not Available

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi,
    Georgia

    Active - Recruiting

  • LTD New Hospitals

    Tbilisi,
    Georgia

    Site Not Available

  • LTD S.Khechinashvili University Hospital

    Tbilisi,
    Georgia

    Site Not Available

  • Multprofil Clinic Consilium Medulla

    Tbilisi,
    Georgia

    Site Not Available

  • Charité - Universitätsmedizin Berlin KöR

    Berlin,
    Germany

    Site Not Available

  • Emovis GmbH

    Berlin,
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald,
    Germany

    Site Not Available

  • Kopfschmerzzentrum Frankfurt am Main

    Hessen,
    Germany

    Site Not Available

  • LMU - Klinikum der Universität München - Campus Grosshadern

    München,
    Germany

    Site Not Available

  • Synexus Polska Sp. z o.o.

    Gdynia,
    Poland

    Site Not Available

  • Centrum Medyczne Neuromed Pawel Lisewski

    Katowice,
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej

    Kraków,
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii Sp. z o.o.

    Kraków,
    Poland

    Active - Recruiting

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.

    Oświęcim,
    Poland

    Site Not Available

  • Hospital Universitari Vall D Hebron

    Barcelona,
    Spain

    Site Not Available

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga,
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico La Fe

    Valence,
    Spain

    Site Not Available

  • Central Research Associates

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • CCT Research

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • HonorHealth Neurology

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Alliance for Multispecialty Research (AMR) Phoenix

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Fullerton Neurological Center

    Fullerton, California 92835
    United States

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Neurological Research Institute of Southern California

    Los Angeles, California 90067
    United States

    Site Not Available

  • SDS Clinical Trials

    Orange, California 92868
    United States

    Site Not Available

  • Visionary Investigators Network (VIN)

    Aventura, Florida 33180
    United States

    Site Not Available

  • AGA Clinical Trials

    Hialeah, Florida 33012
    United States

    Site Not Available

  • ERG - Clinical Pharmacology of Miami

    Miami, Florida 33172
    United States

    Active - Recruiting

  • University of Miami Leonard M. Miller School of Medicine - Professional Arts Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • MD Fort Wayne Neurological Center

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Comprehensive Neurology Services

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Boston Clinical Trials Inc

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts 01609
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • SPRI Clinical Trials, LLC

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Nuvance Health Medical Practice

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Asheville Neurology Specialists

    Asheville, North Carolina 28806
    United States

    Site Not Available

  • Headache Wellness Center

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • OrthoNeuro

    New Albany, Ohio 43054
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Neurology Clinic, PC

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Texas Neurology

    Dallas, Texas 75214
    United States

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • American Research Corporation/Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • J. Lewis Research Inc.-Foothill Family Clinic

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • Metrodora Institute

    West Valley City, Utah 84119
    United States

    Site Not Available

  • Inova Medical Group - Neurology

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • MedStar Health - Department of Neurology

    Columbia, Washington 20010
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia 26537
    United States

    Site Not Available

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