NCT04783766已完成1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects
Corxel Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
研究概览
简要总结
The purposes of this study are to:
- Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
- Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
- Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
- Determine the effect of doses of CK-3773274 on the pumping function of the heart.
- Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese males and females between 18 and 45 years of age, inclusive
- •Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
- •Acoustic windows adequate for accurate transthoracic echocardiograms
- •Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist
- •LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
排除标准
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •Subjects with breast implants that may impede echocardiography
- •A clinically significant illness within 4 weeks prior to admission to the CRU
- •Inability to swallow tablets
- •Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
- •Poor peripheral venous access
- •Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU
研究组 & 干预措施
CK-3773274 for Single Ascending Dose (SAD) Cohorts
Experimental
Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274
干预措施: CK-3773274 (Drug)
Placebo comparator for SAD Cohorts
Placebo Comparator
Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator
干预措施: Placebo (Drug)
CK-3773274 for Multiple Dose (MD) Cohort
Experimental
Subjects will receive multiple doses of CK-3773274
干预措施: CK-3773274 (Drug)
Placebo comparator for MD Cohort
Placebo Comparator
Subjects will receive multiple doses of placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
时间窗: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Reduced Left Ventricular Ejection Fraction (LVEF)
时间窗: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
次要结局
- Cmax of CK-3773274 after single and multiple ascending doses(SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23)
研究者
研究点 (1)
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