A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC from zero to time t of the last measured concentration above the limit of quantification
研究概览
简要总结
A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- •Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period.
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
- •Study-specific criteria
- •Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.
排除标准
- •Previous exposure to clazosentan.
- •Previous exposure to rifampicin within 3 months prior to Screening.
- •Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.
- •Known hypersensitivity or allergy to natural rubber latex.
- •Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- •Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.
- •Positive results from the HIV serology at Screening.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究组 & 干预措施
Treatment sequence AB
Period A:
Saline + clazosentan
Period B:
Rifampicin + clazosentan
干预措施: Clazosentan (Drug)
Treatment sequence AB
Period A:
Saline + clazosentan
Period B:
Rifampicin + clazosentan
干预措施: Rifampicin (Drug)
Treatment sequence AB
Period A:
Saline + clazosentan
Period B:
Rifampicin + clazosentan
干预措施: Saline (0.9% sodium chloride) (Other)
Treatment sequence BA
Period B:
Rifampicin + clazosentan
Period A:
Saline + clazosentan
干预措施: Clazosentan (Drug)
Treatment sequence BA
Period B:
Rifampicin + clazosentan
Period A:
Saline + clazosentan
干预措施: Rifampicin (Drug)
Treatment sequence BA
Period B:
Rifampicin + clazosentan
Period A:
Saline + clazosentan
干预措施: Saline (0.9% sodium chloride) (Other)
结局指标
主要结局
AUC from zero to time t of the last measured concentration above the limit of quantification
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to infinity (AUC0-inf)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
The maximum plasma concentration (Cmax)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Volume of distribution at steady state (Vss)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to 3 h (AUC0-3)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t½)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Total body clearance (CL)
时间窗: 24 hours post treatment infusion initiation
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
次要结局
未报告次要终点