A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.
详细描述
This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening
- •Protocol-defined laboratory and electrocardiogram parameters
- •Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period
- •Agrees to protocol-defined use of effective contraception
- •Willing to be confined at the clinical research facility for time period specified in the protocol
排除标准
- •Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- •History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation
- •Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening
- •Serum testosterone level of <200 ng/dL
- •Use of any tobacco or nicotine-containing products
- •Known or suspected use of illicit drugs in the last year
- •Protocol contraindicated medications/preparations (prescription and non-prescription)
结局指标
主要结局
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
Maximum observed plasma concentration of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
Time to reach the maximum observed plasma concentration of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination rate constant of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination half-life of abiraterone
时间窗: Pre-dose and up to 96 hours post-dose each treatment period
次要结局
- Number of participants with adverse events(Up to 42 days)