Phase
Condition
Primary Biliary Cholangitis
Treatment
BI 1291583
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria :
Male or female trial participants aged ≥18 and ≤80 years at screening
Body Mass Index (BMI) of 18.5 to 42 kg/m² (inclusive)
Signed and dated written informed consent in accordance with International Councilon Harmonisation (ICH) Harmonized Guideline for Good Clinical Practice (GCP) andlocal legislation prior to admission to the trial
Female trial participants who meet any of the following criteria for a highlyeffective contraception from at least 30 days before the first administration oftrial medication until 5 months after trial dosing
Use of combined (oestrogen and progestogen containing) hormonal contraceptionthat prevents ovulation (oral, intravaginal or transdermal), plus condom
Use of progestogen-only hormonal contraception that inhibits ovulation (onlyinjectables or implants), plus condom
Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)plus use of condom
Sexually abstinent
A vasectomised sexual partner who received medical assessment of the surgicalsuccess (documented absence of sperm) and provided that partner is the solesexual partner of the trial participant
Surgically sterilised (including hysterectomy) plus use of condom
Postmenopausal, defined as no menses for 1 year without an alternative medicalcause (in questionable cases a blood sample with levels of Follicle StimulatingHormone (FSH) above 25 U/L and oestradiol below 30 ng/L is confirmatory)
In addition to the overall inclusion criteria given, trial participants with impaired hepatic function must fulfil the following criteria:
Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points) or Child Pugh C (score 10-15 points)
Absence of significant abnormalities, as based on a complete medical historyincluding a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at bothscreening and admission to trial site, with the exception of findings that in theopinion of the investigator are consistent with the participant's hepatic impairment
Medication and/or treatment regimens must have been stable (i. e., no doseadjustments) for at least 7 days or 5 half-lives (whichever is longer) prior to theplanned randomisation and should be kept stable until study completion. Fluctuatingtreatment regimens may be considered for inclusion on a case-by-case basis if theunderlying disease is under control in the opinion of the investigator and must beagreed to by both the investigator and the sponsor's medical monitor
In addition to the overall inclusion criteria given, trial participants with normal hepatic function must fulfill the following criteria:
- Individually matched to trial participation with hepatic impairment according tosex, age, smoking habit and weight
Exclusion
Exclusion Criteria:
Exclusion criteria applying to all trial participants:
Any medical condition or finding in the medical examination that in theinvestigator's opinion assessed as clinically relevant, poses a safety risk for thetrial participant or may interfere with the study objectives (except for conditionsassociated with hepatic impairment in trial participant with compromised hepaticfunction)
Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance (apart from values due to underlying disease)
Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) ChronicKidney Disease Epidemiology (CKD-EPI) <40 ml/min/1.73 m2 for the hepatic impairedtrial participants and Estimated Glomerular Filtration Rate (eGFR) Chronic KidneyDisease Epidemiology (CKD-EPI) <60 ml/min/1.73 m2 for matched controls),respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessedas clinically relevant by the Investigator
Alpha fetoprotein >50 ng/mL (>50 µg/L) at screening
Surgery of the gastrointestinal tract that could interfere with the pharmacokineticsof the trial medication (except cholecystectomy, appendectomy or simple herniarepair)
Diseases of the central nervous system (including but not limited to any kind ofseizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Relevant chronic or acute infections
Further exclusion criteria apply
Study Design
Connect with a study center
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesActive - Recruiting
Tranquil Clinical Research
Houston, Texas 77598
United StatesSite Not Available
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
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