EUCTR2016-002813-24-DE进行中（未招募）1 期
Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushed tablet (adult formulation) in the fasting condition, and to investigate the effect of a high fat, high calorie meal on the suspension in healthy male subjects in a randomized, open-label, four-fold crossover design
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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