A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 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
- Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
研究概览
简要总结
A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 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.
排除标准
- •Known allergic reactions or hypersensitivity to ACT-541468, 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-541468;
- •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
Rosuvastatin Day 1
干预措施: Rosuvastatin (Drug)
Treatment B1
ACT-541468 Day 5 to Day 7
干预措施: ACT-541468 (Drug)
Treatment B2
Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12
干预措施: Rosuvastatin (Drug)
Treatment B2
Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12
干预措施: ACT-541468 (Drug)
结局指标
主要结局
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
时间窗: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
时间窗: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
时间窗: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
时间窗: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
时间窗: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
次要结局
- Treatment-emergent (serious) adverse events(From Screening to EOS (for a maximum of up to 5 weeks))
- Trough concentration (Ctrough) of ACT-541468(During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week)
- Change in vital signs(From Screening to EOS (for a maximum of up to 5 weeks))
- Change in body weight(From Screening to EOS (for a maximum of up to 5 weeks))
- Treatment-emergent ECG abnormalities(From Screening to EOS (for a maximum of up to 5 weeks))
- Change in clinical laboratory tests(From Screening to EOS (for a maximum of up to 5 weeks))
- Change in ECG variables(From Screening to EOS (for a maximum of up to 5 weeks))