A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Incidence and severity of AEs
研究概览
简要总结
- Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects.
- Find out how much CK-3828136 is in the blood after a single dose and multiple doses.
- Determine the effect different doses of CK-3828136 on the pumping function of the heart.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight > 50.0 kg.
排除标准
- •Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:
- •History of any significant illness or disorder.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
- •History or presence of:
- •additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- •sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.
- •Clinically significant illness within 4 weeks prior to check in.
- •Participants with an inability to swallow tablets.
研究组 & 干预措施
Placebo for SAD Cohort
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
干预措施: Placebo for CK-3828136 (Drug)
CK-3828136 for SAD Cohort
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136
干预措施: CK-3828136 (Drug)
CK-3828136 for MAD Cohort
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136
干预措施: CK-3828136 (Drug)
Placebo for MAD Cohort
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
干预措施: Placebo for CK-3828136 (Drug)
Food Effect
Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.
干预措施: CK-3828136 (Drug)
结局指标
主要结局
Incidence and severity of AEs
时间窗: Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2)
To assess the safety and tolerability of CK-3828136 when administered orally as single or multiple doses to healthy participants
次要结局
- Primary PK parameters of CK-3828136 including AUC(Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14; Time Frame for Food Effect Cohorts: Days 1 to 7 (Treatment Periods 1 and 2))
- Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF(Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14)
- PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state(Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2))