NCT03586570已完成1 期
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian Subjects
适应症
干预措施
相关药物
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
- AUCτ on the first and last day of study treatment intake
研究概览
简要总结
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be of Caucasian or Japanese ethnicity
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- •Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
- •Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening
- •A woman of childbearing potential is eligible only if the following applies:
- •Negative serum pregnancy test at Screening,
- •Negative urine pregnancy test on Day -1,
- •Agreement to consistently and correctly use a reliable method of contraception from Screening up to at least 30 days after last study treatment administration
- •Japanese subjects only
- •Subjects must be of native Japanese descent (all parents/grandparents of Japanese descent).
- •Subjects must not have been away from Japan for more than 10 years (at Screening visit).
- •Subject's lifestyle should not have changed significantly since relocation from Japan
排除标准
- •Previous exposure to aprocitentan and/or macitentan.
- •Known hypersensitivity to aprocitentan or treatments of the same class, or any of the excipients
- •Pregnant or lactating women
- •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
Aprocitentan
Experimental
干预措施: Aprocitentan 25mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
AUCτ on the first and last day of study treatment intake
时间窗: From study treatment administration to 216 hours after last administration
Cmax during the first and last dosing interval
时间窗: From study treatment administration to 216 hours after last administration
Time to reach Cmax (tmax) during the first and last dosing interval
时间窗: From study treatment administration to 216 hours after last administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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