EUCTR2016-002895-29-DE进行中（未招募）1 期
Relative bioavailability study to investigate the pharmacokinetics, safetyand tolerability of single oral doses of finerenone 1.25 mg and 5 x 0.25 mgoro-dispersible tablet (pediatric formulation) in comparison to 10 mgtablet (adult formulation) in the fasting condition and to investigate theeffect of a high fat, high calorie meal on 1.25 mg oro-dispersible tablet inhealthy male subjects in a randomized, open-label, four-fold crossoverdesign
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 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
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 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
研究者
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