A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
研究概览
简要总结
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.
- •Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:
- •PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL);
- •Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease
- •Bone disease progression defined by two or more new lesions on bone scan
排除标准
- •Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.
- •History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).
- •Patients who previously received treatment with Enzalutamide.
- •Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C
- •Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
研究组 & 干预措施
Enzalutamide tablet
Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks
干预措施: Enzalutamide tablet (Drug)
Enzalutamide capsule
Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks
干预措施: Enzalutamide capsule (Drug)
结局指标
主要结局
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
时间窗: Day1 through Day 56 (12 samples)
Day 56 (fasted) Cmax under steady state conditions of enzalutamide
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)
时间窗: Day1 through Day 56 (12 samples)
Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide
次要结局
- Pharmacokinetic profile of Enzalutamide under fasted and fed conditions(Day 1, 8, 29, 55, 56 and 57 (38 samples))
- Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002(Day 8, 29, 55, 56 and 57 (26 samples))
- Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments(Day 1 through Day 58)