NCT02894385已完成1 期
A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function
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
- 29
- 主要终点
- Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
研究概览
简要总结
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
详细描述
The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All subjects
- •- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg/m*2 (both inclusive).
- •Patients with moderate hepatic impairment (Part 1)
- •- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).
- •Patients with severe renal impairment (Part 1)
- •- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m*2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).
- •Healthy subjects
- •- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate >90 mL/min (according to Modified Diet of Renal Disease equation).
- •Patients with moderate renal impairment (Part 2)
- •- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL/min/1.73 m*2 (Stage 3).
- •Patients with mild renal impairment (Part 2)
- •- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL/min/1.73 m*2 (Stage 2).
- •Patients with mild hepatic impairment (Part 2)
- •Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan.
- •Patients with mild hepatic impairment (defined as Child Pugh class A).
排除标准
- •Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV.
- •Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration.
- •Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- •Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.
- •Smoking more than 20 cigarettes daily.
研究组 & 干预措施
Part 1 - Subjects with moderate hepatic impairment
Experimental
Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).
干预措施: BAY1841788 (Drug)
Part 1 - Subjects with severe renal impairment
Experimental
Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).
干预措施: BAY1841788 (Drug)
Part 1 - Healthy subjects
Experimental
Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).
干预措施: BAY1841788 (Drug)
结局指标
主要结局
Area under the concentration-time curve of darolutamide from time zero to 48 hours (AUC(0-48)) in plasma
时间窗: Pre-dose up to 48 h post dose
Maximum drug concentration (Cmax) of darolutamide in plasma
时间窗: Pre-dose up to 48 h post dose
次要结局
- Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,R)-darolutamide) in plasma(Pre-dose up to 48 h post dose)
- Area under the concentration-time curve of darolutamide's diastereomer ((S,R)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma(Pre-dose up to 48 h post dose)
- Maximum drug concentration (Cmax) of darolutamide's diastereomer ((S,S)-darolutamide) in plasma(Pre-dose up to 48 h post dose)
- Number of subjects with study drug-related treatment-emergent adverse events (TEAEs)(From first application of study medication up to 30 days after end of treatment with study medication.)
- Area under the concentration-time curve of darolutamide's diastereomer ((S,S)-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma(Pre-dose up to 48 h post dose)
- Area under the concentration-time curve of darolutamide's major metabolite (keto-darolutamide) from time zero to 48 hours (AUC(0-48)) in plasma(Pre-dose up to 48 h post dose)
- Maximum drug concentration (Cmax) of darolutamide's major metabolite (keto-darolutamide) in plasma(Pre-dose up to 48 h post dose)
研究者
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