A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin 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
- Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577
研究概览
简要总结
The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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;
- •Healthy male subjects aged 18 to 45 years (inclusive) at screening;
- •Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
- •Hemoglobin ≥ 135 g/L at screening.
排除标准
- •Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;
- •Any contraindication for rosuvastatin treatment;
- •History or clinical evidence of myopathy;
- •Asian or Indian-Asian ethnicity;
- •Known hypersensitivity or allergy to natural rubber latex;
- •Previous exposure to ACT-132577;
- •Treatment with rosuvastatin within 3 months prior to 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 A
In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h
干预措施: Rosuvastatin (Drug)
Treatment B1
25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12
干预措施: Aprocitentan (Drug)
Treatment B2
In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h.
Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17.
干预措施: Aprocitentan (Drug)
Treatment B2
In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h.
Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577
时间窗: Up to Day 29
Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile
Maximum plasma concentration (Cmax) of rosuvastatin
时间窗: Up to Day 29
Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time to reach Cmax (tmax) of rosuvastatin
时间窗: Up to Day 29
tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t1/2) of rosuvastatin
时间窗: Up to Day 29
t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin
时间窗: Up to Day 29
AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin
时间窗: Up to Day 29
AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile
次要结局
- Changes from baseline in blood pressure(Up to Day 29)
- Number of participants with adverse events (AEs)(Up to Day 29)
- Changes from baseline in electrocardiogram (ECG) variables(Up to Day 29)
- Changes from baseline in pulse rate(Up to Day 29)