A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of a Probe CYP3A4 Inhibitor and Inducer on the Pharmacokinetics of BAY1841788 (ODM 201) in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
研究概览
简要总结
Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.
- •Gender: Male.
- •Age: 45 to 65 years (inclusive) at the screening visit.
- •Race: White.
- •Body mass index (BMI): ≥18.0 and ≤30 kg/m^
- •Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with ODM-
- •In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception.
- •Results of alcohol tests are negative at screening and on Study Day -1.
排除标准
- •Medical and surgical history
- •Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).
- •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.
- •Febrile illness within 1 week before the first study drug administration.
- •A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias.
- •Known severe allergies, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated, asymptomatic seasonal allergies like non-severe hay fever during the time of study conduct).
- •Known history of hypersensitivity (or known allergic reaction) to itraconazole, rifampicin or ODM-
- •Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
- •Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.
- •Subjects with porphyria.
- •Subjects with diagnosed malignancy within the past 5 years except for cured skin basal carcinoma.
研究组 & 干预措施
ODM-201
All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period
干预措施: BAY1841788 (ODM-201) (Drug)
ODM-201
All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period
干预措施: Itraconazole (Drug)
ODM-201
All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period
干预措施: Rifampicin (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration after single dose administration in plasma were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours (AUC\[0-72h\]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.
Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide
时间窗: Pre dose up to 72 hours post dose of darolutamide
Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.
次要结局
- Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs)(From start of study drug administration up to 30 days after last dose of study medication)