A Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Effect of Multiple-dose Diltiazem on the Pharmacokinetics of a Single Dose of 25 mg ACT-541468 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
- Maximum plasma concentration (Cmax) of ACT-541468
研究概览
简要总结
The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468
详细描述
Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468.
Safety of the concomitant administration of the two drugs will also be assessed
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening
- •Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests
排除标准
- •Any contraindication to the study drugs
- •History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
- •History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
研究组 & 干预措施
Sequence AB
During Period 1, subjects receive a single dose of ACT-541468 on Day 1. During Period 2, they receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4
干预措施: ACT-541468 (Drug)
Sequence AB
During Period 1, subjects receive a single dose of ACT-541468 on Day 1. During Period 2, they receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4
干预措施: Diltiazem (Drug)
Sequence BA
During Period 1, subjects receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4. During Period 2, they receive a single dose of ACT-541468 on Day 1
干预措施: ACT-541468 (Drug)
Sequence BA
During Period 1, subjects receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4. During Period 2, they receive a single dose of ACT-541468 on Day 1
干预措施: Diltiazem (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of ACT-541468
时间窗: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)
Cmax will be directly derived from the plasma concentration time curves of ACT-541468
Time to reach Cmax of ACT-541468 in plasma
时间窗: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA
tmax will be directly derived from the plasma concentration time curves of ACT-541468
Area under the plasma concentration-time curve (AUC) of ACT-541468
时间窗: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)
AUC will be calculated for the following time frame: from time zero to the last measured concentration above the limit of quantification and from time zero to infinitiy
次要结局
未报告次要终点