Phase
Condition
Primary Biliary Cholangitis
Treatment
Avenciguat (BI 685509)
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects 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 Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial
Either male subject, or female subject who meet any of the following criteria for ahighly effective contraception from at least 30 days before the first administrationof trial medication until 30 days after trial completion:
Use of combined (estrogen 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)
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)
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 40 U/L and estradiol below 30 ng/L is confirmatory)
Applying only to participants with impaired hepatic function:
Stable hepatic impairment (Child-Pugh score 10 - 15 point consistent with severehepatic impairment) due to parenchymal liver disease, which is confirmed anddocumented by at least one of the following: medical history, physical examination,hepatic ultrasound, computed tomography (CT) scan, magnetic resonance imaging (MRI),and/or liver biopsy and defined as no clinically significant change in diseasestatus within 4 weeks, as judged by the Investigator
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 hepaticimpairment.
Medication and/or treatment regimens must have been stable (i.e., no doseadjustments) for at least 7 days or 5 half-lives whichever 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.
Applying only to healthy participants with normal hepatic function:
- Healthy subjects according to the assessment of the investigator (as based on acomplete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests), and individually matched to participantswith hepatic impairment according to sex, age and weight.
Exclusion
Exclusion Criteria:
Any medical condition or finding in the medical examination that in theinvestigator's opinion assessed as clinically relevant, poses a safety risk for thesubject or may interfere with the study objectives (except for conditions associatedwith hepatic impairment in subjects with compromised hepatic function)
Repeated measurement of systolic blood pressure outside the range of 100 to 150millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 70 to 100 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any surgical or medical condition that may significantly interfere with thepharmacokinetics of the trial medication (eg, prior bariatric surgery, gastrectomy,ileal resection)
History of relevant orthostatic hypotension, fainting spells, or blackouts
History of relevant allergy or hypersensitivity (including allergy to the trialmedication or its excipients)
Any documented active or suspected malignancy or history of malignancy within 5years prior to screening, except appropriately treated basal cell carcinoma of theskin
Intake of restricted concomitant therapy or any concomitant therapy consideredlikely (based on Investigator judgement) to interfere with the safe conduct or mayinfluence the primary and/or secondary endpoints of the trial within 30 days or 5half-lives whichever longer prior to planned administration of the trial medication.
Ongoing chronic alcohol or drug use, that in the investigator's opinion, makes thepatient an unreliable trial participant or unlikely to complete the trial.
Further exclusion criteria apply.
Study Design
Connect with a study center
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesSite Not Available
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
United StatesSite Not Available
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