A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
研究概览
简要总结
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.
Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening).
- •Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration.
- •Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration.
排除标准
- •Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- •Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
- •Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
- •The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in.
- •Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject.
- •Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
研究组 & 干预措施
Treatment A
Single dose of 4 liquid-filled capsules of MDV3100 reference formulation
干预措施: MDV3100 (Drug)
Treatment B
Single dose of 2 tablets of MDV3100 formulation tablet B
干预措施: MDV3100 (Drug)
Treatment C
Single dose of 2 tablets of MDV3100 formulation tablet C
干预措施: MDV3100 (Drug)
结局指标
主要结局
Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
时间窗: Day 1 through Day 50 (26 times)
AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)
次要结局
- Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions(Day 1 through Day 50 (26 times))
- Safety and tolerability of oral formulations of enzalutamide(Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal))