NCT02671097已完成1 期
A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum drug concentration (Cmax) in plasma of Rosuvastatin
研究概览
简要总结
Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics.
PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
- •Age: 45 to 65 years at the screening visit.
- •Race: White.
- •Body mass index (BMI): ≥18.0 and ≤29.9 kg/m*
- •Adequate venous access (frequent blood sampling).
- •Ability to understand and follow study-related instructions.
- •Females have to be in postmenopausal state, revealed by: Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drugadministration) and follicle stimulating hormone (FSH) >40 IU/L at screening examination.
- •Male subjects must agree to use condoms as an effective contraception barrier method during the whole study (starting after informed consent) and for 3 months after the end of treatment with BAY1841788 (ODM-201). 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.
排除标准
- •Medical and surgical history
- •Subjects with clinically relevant findings in medical history e.g. history or currently existing relevant diseases of vital organs, 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 interval in electrocardiogram Syndrome) or other arrhythmias.
- •History of myopathia after treatment with statins.
- •History of rhabdomyolysis or myopathia.
- •Medical history of any type of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts.
- •History of thyroid disorders, especially hypothyreosis.
- •History of respiratory disorder (excluding history of bronchitis or pneumonia).
- •History of myasthenia.
- •History of muscle pain or muscle ache, muscle soreness of unknown origin or on frequent occasions although an origin might have been found.
- •History of any clinically significant hypoglycemia or hyperglycemia.
- •Relevant hepatic disorders like a history of viral hepatitis, 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.
研究组 & 干预措施
BAY1841788 (ODM-201) + Rosuvastatin
Experimental
All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin (5 mg), once alone and once in combination with BAY1841788 (ODM-201).
干预措施: Rosuvastatin (Drug)
BAY1841788 (ODM-201) + Rosuvastatin
Experimental
All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin (5 mg), once alone and once in combination with BAY1841788 (ODM-201).
干预措施: BAY1841788 (ODM-201) (Drug)
结局指标
主要结局
Maximum drug concentration (Cmax) in plasma of Rosuvastatin
时间窗: Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24))
时间窗: Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
次要结局
- Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration(Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h after BAY1841788 administration, period 2 day 7)
- Number of subjects with study drug-related treatment-emergent Adverse Events(Up to 30 days)
- Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration(Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration, period 2 day 1)
- Maximum drug concentration (Cmax) in plasma of BAY1841788(Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration)
研究者
研究点 (1)
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