NL-OMON53911招募中不适用
Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-111 and effect of food on the pharmacokinetics of ODM-111 and pharmacokinetic drug-drug interaction potential of ODM-111 - FIMCARE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Subjects must meet all of the following criteria to be included into the study:
- •1. Written informed consent (IC) obtained
- •2. Good general health ascertained by detailed medical history and laboratory
- •and physical examinations.
- •3. Males and females between 18 and 55 years (inclusive).
- •4. Body mass index (BMI) between 18-32 kg/m2 (inclusive) (BMI = weight/height2).
- •5. Weight 50-120 kg (inclusive).
- •6. Female participants with fertile male partner, and male participants with
- •female partners of child-bearing potential, must adhere to a highly effective
- •form of contraception (e.g. combined or progestogen only hormonal
- •contraceptives associated with inhibition of ovulation, intrauterine devices or
- •intrauterine hormone-releasing system; for Part III and Part V, all combined
- •with a male or female condom with diaphragm, sponge or cervical cap), if
- •sexually active and not permanently sterilised, for females from 4 weeks before
- •the first study treatment administration, and for males from admission to study
- •centre until 3 months after the end-of-study visit. Additionally, women who are
- •postmenopausal (1 year since last menstrual cycle) are considered not to be
- •reproductive and can be included. For male subjects, sperm donation is not
- •allowed until 3 months after the end-of-study visit.
排除标准
- •Subjects will not be included into this study if they meet any of the following
- •criteria: 1. A predictable poor compliance or inability to understand and
- •comply with protocol requirements, instructions and protocol-stated
- •restrictions or communicate well with the investigator 2. Veins unsuitable for
- •repeated venipuncture or for cannulation. 3. Evidence of clinically significant
- •cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary,
- •immunologic, dermatologic, metabolic-endocrine, neurological, urogenital,
- •psychiatric and/or other major disease as judged by the investigator. Any
- •surgical or medical condition (including cholecystectomy) which might
- •significantly alter the absorption, distribution, metabolism or excretion of
- •any drug. 4. Part I: Any current, clinically significant, known medical
- •condition that would affect sensitivity to cold (such as atherosclerosis,
- •Raynaud*s disease, urticaria, hypothyroidism) or pain (i.e., disease that
- •causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy).
- •5. Part I: Intolerance of PainCart tests or tolerance at > 80% of maximum input
- •intensity for any pain test for cold. 6. Obsolete exclusion criteria removed in
- •Amendment 5. 7. Any confirmed significant allergic reactions (urticaria or
- •anaphylaxis) against any drug, (in Part III allergic reactions against
- •losartan, omeprazole, dextromethorphan or midazolam and in Part V dabigatran
- •etexilate and rosuvastatin) or multiple drug allergies (non-active hay fever is
- •acceptable). 8. Intake of any medication that could affect the outcome of the
- •study, as judged by the investigator, within 2 weeks before the first study
- •treatment administration (1 month for enzyme inducing drugs like rifampicin or
- •carbamazepin), 4 weeks for live vaccines and 2 weeks for other vaccines
- •including COVID-19 vaccines. 9. A history of alcoholism or current excess
- •alcohol intake (including regular consumption of more than 2 units daily on
- •average [1 unit = approximately 250 ml of beer, 100 ml of wine, or 35 m of
- •spirits]); inability to refrain from the intake of alcohol from 48 h before the
- •first study treatment administration and during the stay at the study site
- •(Part I, Part II and Part IV) and during the Part III until Day 17 and during
- •the Part V until Day 22. 10. Part I : Use of nicotine-containing products
- •within 3 months before screening. Part II-Part V: Current use of
- •nicotine-containing products on a daily basis. 11. Inability to refrain from
- •using nicotine-containing products during the stay at the study centre. 12.
- •History of drug abuse within 2 years or positive drug screen at screening. 13.
- •Inability to refrain from methylxanthine-containing beverages or food (coffee,
- •tea, cola, chocolate, energy drinks) from 48 hours (2 days) before the first
- •study treatment administration and during the stay at the study site. 14. Blood
- •donation or loss of significant amount of blood (>= 500 ml) within 3 months
- •before the admission to study centre. 15. Abnormal 12-lead ECG finding of
- •clinical relevance at the screening visit, (after 5 min rest in supine
- •position, confirmed by a repeat measurement) for example: • QTc (calculated
- •through the Fridericia*s formula) > 450 msec for male and > 470 msec for female
- •subjects (If QTc interval measured by the ECG machine algorithm
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