An Open-Label Drug-Drug Interaction Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2
研究概览
简要总结
The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.
详细描述
This is an open-label (all people know the identity of the intervention), single-center (study conducted at one site), 2-period, sequential-design (studies that combine both longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 14 days before the first study medication administration. The treatment phase will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at least 7 days. Blood sample collection for pharmacokinetic assessments will be done for determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. The total study duration will be approximately 31 days.
研究设计
- 研究类型
- Interventional
- 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
- •Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- •Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
- •Must sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- •Have willingness to participate in the optional pharmacogenomic component of this study, participants (or their legally acceptable representative) must have signed the informed consent form
排除标准
- •History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, and others
- •Clinically significant abnormal values for hematology or clinical chemistry at screening or at admission to the study center
- •Serum testosterone level of < 200 ng/dL (at screening)
- •Clinically significant renal laboratory findings including specifically, creatinine, and creatinine clearance
- •Clinically significant hepatic laboratory findings or signs
研究组 & 干预措施
Abiraterone acetate + Rifampicin
Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 1 of Period 1. Rifampicin 600 mg (2 x 300 mg) on Days 8 to 13, and Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 14 of Period 2.
干预措施: Rifampicin (Drug)
Abiraterone acetate + Rifampicin
Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 1 of Period 1. Rifampicin 600 mg (2 x 300 mg) on Days 8 to 13, and Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 14 of Period 2.
干预措施: Abiraterone acetate (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2
时间窗: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
Pharmacokinetic parameter Cmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.
Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2
时间窗: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
Pharmacokinetic parameter AUC of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.
Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2
时间窗: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
Pharmacokinetic parameter tmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.
Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2
时间窗: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
Pharmacokinetic parameter t1/2 of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.
次要结局
- Number of participants with adverse events(Up to 31 days)