Treatment of diabetic kidney disease (adults) and chronic kidney disease (children).
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The informed consent must be signed before any study specific tests or procedures are done 2. Healthy male subject 3. Age: 18 to 45 years (inclusive) at the first screening examination/visit 4. Race: White 5. Body mass index (BMI): =18 and =29.9 kg/ m² 6. Ability to understand and follow study-related instructions 7. Confirmation of the subject’s health insurance coverage prior to the first screening examination/ visit 8. Male subjects with a female partner of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condom or diaphragm or cervical cap with hormonal contraception, condom or diaphragm or cervical cap with an intrauterine device). This applies for the time period between signing of the informed consent form and 1 week after the last administration of study drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical and surgical history 1.Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator 2.A history of relevant diseases of vital organs, of the central nervous system or other organs 3.Known renal or liver insufficiency 4.Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening) 5.Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator 6.Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal 7.Known hypersensitivity to the study drugs (active substances or excipients of the preparations) 8.Known hypersensitivity to components of the American breakfast 9.Known severe allergies, non-allergic drug reactions, or multiple drug allergies 10.Relevant diseases within the last 4 weeks prior to the first study drug administration 11.Febrile illness within 1 week before the first study drug administration Medication, drug use and special behavioral patterns 12.Regular use of medicines 13.Use of prohibited medicines/substances defined in protocol (e.g. CYP3A4 inducers, CYP3A4 inhibitors) within 2 weeks before the first study drug administration 14.Regular use of therapeutic or recreational drugs, e.g. carnitine products, anabolics, high dose vitamins 15.Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration 16.Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form 17.Suspicion of drug or alcohol abuse 18.Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it 19.Regular daily consumption of more than 1 L of xanthine-containing beverages 20.Intake of foods or beverages containing grapefruit, pomelo, or Seville oranges within 2 weeks before the first study drug administration until follow-up 21.Intake of St John’s Wort within 2 weeks before the first study drug administration until follow-up 22.Donation of more than 100 mL of blood within 4 weeks before the first study drug administration 23.Donation of more than 500 mL of blood within 3 months before the first study drug administration 24.Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment Electrocardiogram (ECG), blood pressure, heart rate 25.Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the QTcB-interval over 450 msec 26.Systolic blood pressure below 100 or above 140 mmHg 27.Diastolic blood pressure below 60 or above 90 mmHg 28.Heart rate below 50 or above 90 beats/ min Physical examination 29.Clinically relevant findings in the physical examination Laboratory examination 30.Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immunodeficiency virus antibodies (anti-HIV 1+2) 31.Positive urine drug screening 32.Positive alcohol breath test 33.Clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to -investigate the relative bioavailability of a single oral dose of 1.25 mg finerenone ODT and 5 x 0.25 mg ODT (pediatric formulation) in comparison to 10 mg finerenone (adult formulation) tablet in the fasting condition -investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 1.25 mg finerenone ODT -investigate whether the finerenone ODTs are palatable and swallowable;Secondary Objective: The secondary objective of this study is to -investigate the safety and tolerability of single oral doses of finerenone;Primary end point(s): AUC/D* and Cmax/D of finerenone * AUC(0-tlast)/D will be used as main parameter if mean AUC(tlast-8) >20% of AUC ;Timepoint(s) of evaluation of this end point: Blood-plasma sampling for finerenone will be performed from pre-dose up to 24 hours after drug administration in each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Germany
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed