Phase I relative bioavailability and food effect study

Phase 1

Conditions: Diabetic kidney disease
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-002813-24-DE

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

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 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

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 (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 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.Clinically relevant deviations of the screened

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to<br>•investigate the relative bioavailability of a single oral dose of 20 mg finerenone suspension and 20 mg crushed and resuspended tablet in comparison to 20 mg finerenone tablet in the fasting condition<br>•investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 20 mg finerenone suspension<br>•investigate whether 20 mg finerenone suspension and 20 mg crushed and resuspended tablet are palatable and swallowable<br>;Secondary Objective: The secondary objective of this study is to<br>•investigate the safety and tolerability of single oral doses of finerenone<br>;Primary end point(s): AUC* and Cmax of finerenone<br><br>* AUC(0-tlast) will be used as main parameter if mean AUC(tlast-8) >20% of AUC<br>;Timepoint(s) of evaluation of this end point: Blood sampling for finerenone will be performed from pre-dose up to 24 hours after drug administration in each treatment period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

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