A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum observed plama concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 in the local language prior to any study-mandated procedure
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests
排除标准
- •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 B2 (Midazolam + ACT-132577)
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
干预措施: Aprocitentan (Drug)
Treatment A (Midazolam)
Single dose of Midazolam 8 mg on Day 1
干预措施: Midalozam (Drug)
Treatment B1 (ACT-132577)
Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5.
干预措施: Aprocitentan (Drug)
Treatment B2 (Midazolam + ACT-132577)
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
干预措施: Midalozam (Drug)
结局指标
主要结局
Maximum observed plama concentration (Cmax)
时间窗: Midazolam PK sampling on Days 1, 2, 6 and 7
Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
时间窗: Midazolam PK sampling on Days 1, 2, 6 and 7
AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time to reach Cmax (tmax)
时间窗: Midazolam PK sampling on Days 1, 2, 6 and 7
Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Terminal half-life (t1/2)
时间窗: Midazolam PK sampling on Days 1, 2, 6 and 7
T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
次要结局
- Number of subjects with adverse events(From Day 1 to Follow-up (for up to 38 days))
- Number of subjects with serious adverse events(From Screening to Follow-up (for up to 59 days))