Phase
Condition
Primary Biliary Cholangitis
Treatment
Palovarotene
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
McGill University Health Centre - The Neuro
Montréal,
CanadaSite Not Available
CARe Clinic
Red Deer,
CanadaSite Not Available
Bluewater Clinical Research Group Inc.
Sarnia,
CanadaSite Not Available
Neurologie Brno s.r.o.
Brno,
CzechiaSite Not Available
Pratia Brno s.r.o.
Brno,
CzechiaActive - Recruiting
NEUROHK s.r.o.
Choceň,
CzechiaSite Not Available
Nemocnice Jihlava, p.o.
Jihlava,
CzechiaSite Not Available
Fakultni nemocnice Ostrava
Ostrava,
CzechiaSite Not Available
Axon Clinical, s.r.o.
Praha,
CzechiaActive - Recruiting
DADO MEDICAL s.r.o.
Praha,
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Praha,
CzechiaActive - Recruiting
Institut neuropsychiatricke pece
Praha,
CzechiaActive - Recruiting
CHRU d'Amiens
Amiens,
FranceSite Not Available
CHU Nimes - Hôpital Caremeau
Nîmes,
FranceSite Not Available
Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
Paris,
FranceSite Not Available
Ltd "Health"
Batumi,
GeorgiaSite Not Available
"Pineo Medical Ecosystem" LTD
Tbilisi,
GeorgiaSite Not Available
ISR-GEO Med Res Clin Healthycore
Tbilisi,
GeorgiaActive - Recruiting
LTD New Hospitals
Tbilisi,
GeorgiaSite Not Available
LTD S.Khechinashvili University Hospital
Tbilisi,
GeorgiaSite Not Available
Multprofil Clinic Consilium Medulla
Tbilisi,
GeorgiaSite Not Available
Charité - Universitätsmedizin Berlin KöR
Berlin,
GermanySite Not Available
Emovis GmbH
Berlin,
GermanyActive - Recruiting
Universitätsmedizin Greifswald
Greifswald,
GermanySite Not Available
Kopfschmerzzentrum Frankfurt am Main
Hessen,
GermanySite Not Available
LMU - Klinikum der Universität München - Campus Grosshadern
München,
GermanySite Not Available
Synexus Polska Sp. z o.o.
Gdynia,
PolandSite Not Available
Centrum Medyczne Neuromed Pawel Lisewski
Katowice,
PolandSite Not Available
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
Kraków,
PolandSite Not Available
Krakowska Akademia Neurologii Sp. z o.o.
Kraków,
PolandActive - Recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim,
PolandSite Not Available
Hospital Universitari Vall D Hebron
Barcelona,
SpainSite Not Available
Complejo Hospitalario Ruber Juan Bravo
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Regional Universitario de Málaga
Málaga,
SpainSite Not Available
Hospital Universitario y Politécnico La Fe
Valence,
SpainSite Not Available
Central Research Associates
Birmingham, Alabama 35205
United StatesSite Not Available
CCT Research
Phoenix, Arizona 85044
United StatesSite Not Available
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesSite Not Available
Alliance for Multispecialty Research (AMR) Phoenix
Tempe, Arizona 85281
United StatesSite Not Available
Fullerton Neurological Center
Fullerton, California 92835
United StatesSite Not Available
Neurology Center of North Orange County
Fullerton, California 92835
United StatesActive - Recruiting
Neurological Research Institute of Southern California
Los Angeles, California 90067
United StatesSite Not Available
SDS Clinical Trials
Orange, California 92868
United StatesSite Not Available
Visionary Investigators Network (VIN)
Aventura, Florida 33180
United StatesSite Not Available
AGA Clinical Trials
Hialeah, Florida 33012
United StatesSite Not Available
ERG - Clinical Pharmacology of Miami
Miami, Florida 33172
United StatesActive - Recruiting
University of Miami Leonard M. Miller School of Medicine - Professional Arts Center
Miami, Florida 33136
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesActive - Recruiting
Conquest Research
Winter Park, Florida 32789
United StatesSite Not Available
MD Fort Wayne Neurological Center
Fort Wayne, Indiana 46804
United StatesSite Not Available
Comprehensive Neurology Services
Frederick, Maryland 21702
United StatesSite Not Available
Boston Clinical Trials Inc
Boston, Massachusetts 02131
United StatesSite Not Available
New England Regional Headache Center, Inc.
Worcester, Massachusetts 01609
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Minneapolis Clinic of Neurology
Burnsville, Minnesota 55337
United StatesSite Not Available
SPRI Clinical Trials, LLC
Brooklyn, New York 11235
United StatesSite Not Available
Nuvance Health Medical Practice
Poughkeepsie, New York 12601
United StatesSite Not Available
Rochester Clinical Research, Inc
Rochester, New York 14609
United StatesSite Not Available
Asheville Neurology Specialists
Asheville, North Carolina 28806
United StatesSite Not Available
Headache Wellness Center
Greensboro, North Carolina 27405
United StatesSite Not Available
OrthoNeuro
New Albany, Ohio 43054
United StatesSite Not Available
Suburban Research Associates
Media, Pennsylvania 19063
United StatesSite Not Available
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina 29405
United StatesSite Not Available
Neurology Clinic, PC
Cordova, Tennessee 38018
United StatesSite Not Available
Texas Neurology
Dallas, Texas 75214
United StatesSite Not Available
Research Your Health
Plano, Texas 75093
United StatesSite Not Available
American Research Corporation/Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
J. Lewis Research Inc.-Foothill Family Clinic
Salt Lake City, Utah 84109
United StatesSite Not Available
Metrodora Institute
West Valley City, Utah 84119
United StatesSite Not Available
Inova Medical Group - Neurology
Fairfax, Virginia 22031
United StatesSite Not Available
MedStar Health - Department of Neurology
Columbia, Washington 20010
United StatesSite Not Available
Frontier Clinical Research, LLC
Kingwood, West Virginia 26537
United StatesSite Not Available
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