Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04881994
Eligibility Criteria:
Inclusion Criteria:
All participants
* The informed consent must be signed before any study specific tests or procedures are done;
* Male and female white participants;
* Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). This applies from signing the informed consent form until follow up visit.
* Body mass index (BMI): 18 to 34 kg/m2 (both inclusive);
* Age: 18 to 79 years (both inclusive) at the screening visit;
* Men must agree to use adequate contraception when being sexually active. This applies from signing of the informed consent until 12 weeks after the last study drug administration. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices);
* Ability to understand and follow study-related instructions.
Participants with hepatic impairment
* Participants with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan;
* Participants with hepatic impairment (Child Pugh A or B);
* Participants with stable liver disease in the last 2 months.
Healthy participants
* Healthy male and female white participants;
* Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than +/-10 years and +/-10 kg;
* Gender matched.
Exclusion Criteria:
All participants
* Participants with a medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor;
* Medical history of Kock pouch (ileostomy after proctocolectomy);
* Febrile illness within 1 week prior to admission to study center;
* Relevant diseases within the last 4 weeks prior to admission;
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies;
* Known hypersensitivity to the study drugs;
* Participants with diagnosed malignancy within the past 5 years;
* Participants with psychiatric disorders which may disable the participants to consent;
* Use of the following co-medications from 2 weeks before until 4 days after study drug administration:
* CYP3A4 inducers (e.g. St. John´s wort, rifampicin, carbamazepin, phenytoin, phenobarbital, bosentan, efavirenz, etravirine, nevirapine)
* weak to moderate CYP3A4 inhibitors (e.g. grapefruit juice and other grapefruit containing products, erythromycin, saquinavir, amiodarone, verapamil, fluconazole, diltiazem)
* strong inhibitors of CYP3A4 (e.g. itraconazole, ketoconazol, posaconazole, voriconazole, atazanavir, ritonavir, nelfinavir or other inhibitors of human immunodeficiency virus (HIV) protease, clarithromycin, telithromycin, nefazodon, telaprevir, boceprevir) or
* gemfibrozil (a strong inhibitor of CYP2C8)
* Positive urine drug screening;
* For women of childbearing potential: positive pregnancy test;
* Positive results for human immunodeficiency virus 1 and 2 antibodies (HIV-Ag/Ab).
Participants with hepatic impairment
* Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring antiarrhythmic treatment;
* Evidence of hepatic encephalopathy related to chronic liver disease \>grade 2 (exclusion by Number Connection Test (NCT);
* Participants with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration;
* History of bleeding within the past 3 months;
* Thrombotic disorder;
* Participants with diabetes mellitus with a glycohemoglobin A1c (HbA1c) \>10%;
* Severe ascites of more than 6 L (estimated by ultrasound);
* Participants with primary and secondary biliary cirrhosis;
* Participants with sclerosing cholangitis;
* Failure of any other major organ system other than the liver;
* Severe infection, malignancy, or psychosis, or any clinically significant illness within 4 weeks prior to study drug administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04881994
Study Brief:
Protocol Section:
NCT04881994