A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence and severity of AEs
研究概览
简要总结
The purposes of this study are to:
- Learn about the safety and tolerability of CK 4021586 after a single dose and multiple doses in healthy subjects.
- Find out how much CK-4021586 is in the blood after a single dose and multiple doses.
- Determine the effect different doses of CK-4021586 on the pumping function of the heart.
- Determine the effect of food in the stomach on how much CK-4021586 is in the blood after a single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 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 55 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
- •Significant history or clinical manifestation of any significant metabolic, allergic/immunologic, dermatologic, hepatic, renal, hematologic, respiratory, cardiovascular (including arrhythmia), gastrointestinal, gallbladder/biliary, musculoskeletal, neurologic, or psychiatric disorder in the opinion of the Investigator or designee.
- •History of significant hypersensitivity or allergy to any drug compound or other substance, unless approved by the Investigator and the Sponsor's Medical Monitor.
- •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).
- •Participants with breast implants that may impede echocardiography
- •Clinically significant illness within 4 weeks prior to check in.
- •Significant ECG abnormalities (heart block, prolonged QT interval, arrhythmia)
- •History of, or current substance abuse (drug or alcohol), known drug or alcohol dependence within the last 2 years prior to Screening, or positive test for drugs of abuse during the screening period
- •Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study, in the judgment of the Investigator
研究组 & 干预措施
CK-4021586 for SAD Cohort
Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586
干预措施: CK-4021586 (Drug)
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-4021586 (Drug)
CK-4021586 for MAD Cohort
Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586
干预措施: CK-4021586 (Drug)
Placebo for MAD Cohort
Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo
干预措施: Placebo for CK-4021586 (Drug)
Food Effect
Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion
干预措施: CK-4021586 (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-4021586 when administered orally as single or multiple doses to healthy participants
次要结局
- Primary PK parameters of CK-4021586 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)