A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax of ODM-201
研究概览
简要总结
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (IC) obtained.
- •Histologically confirmed adenocarcinoma of prostate
- •Progressive metastatic disease
- •Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
- •Adequate bone marrow, hepatic and renal function
- •Able to swallow the ODM-201 whole as a capsule or tablet.
排除标准
- •Previous chemotherapy for prostate cancer.
- •Known metastases in the brain.
- •History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
- •Known gastrointestinal condition that can significantly affect the absorption of the study treatment.
研究组 & 干预措施
ODM-201 Tablet A
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
干预措施: ODM-201 Tablet A (Drug)
ODM-201 Tablet A
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
干预措施: ODM-201 capsule formulation (Drug)
ODM-201 Tablet B
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
干预措施: ODM-201 Tablet B (Drug)
ODM-201 Tablet B
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
干预措施: ODM-201 capsule formulation (Drug)
结局指标
主要结局
Cmax of ODM-201
时间窗: 0-48 hrs
The plasma peak concentration.
Area under the curve (AUC) of ODM-201
时间窗: 0-48 hrs
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
次要结局
- Terminal elimination rate constant of ODM-201(0-48 hrs)
- tmax of ODM-201(0-48 hrs)
- Terminal elimination half-life of ODM-201(0-48 hrs)