NCT03281122终止1 期
A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986224 in Healthy Subjects and Chronic Heart Failure Patients With Reduced Ejection Fraction
Bristol-Myers Squibb18 个研究点 分布在 5 个国家目标入组 199 人开始时间: 2017年9月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 199
- 试验地点
- 18
- 主要终点
- Number of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is test the safety and tolerability of BMS-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction
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
- Double (Participant, Investigator)
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 Subjects (Part A and B)
- •Healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
- •Subjects must be willing and able to complete all study-specific procedures and visits
- •Additional criterion for Japanese subjects in Groups BJ1 to BJ3: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese)
- •Heart Failure Patients (Part C)
- •Left ventricular EF <45% and >25%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF <40% and >25% as assessed by echocardiogram at Screening or within 3 months of first dose of study drug; left ventricular EF
- •Heart failure is considered to be stable at the discretion of the Investigator (i.e., no acute cardiovascular [CV] events or hospitalization (including emergency room visits) for CV causes within 3 months of first dose of study drug
- •Regular sinus rhythm at Screening and no history of atrial fibrillation in the past 12 months
排除标准
- •Healthy Subjects (Part A and B)
- •Major surgery within 4 weeks of (first) study treatment administration
- •Inability to be venipunctured and/or tolerate venous access
- •Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug
- •Heart Failure Patients (Part C)
- •Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- •Major surgery within 4 weeks of (first) study treatment administration
- •Inability to be venipunctured and/or tolerate venous access
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Arm A
Experimental
Specified dose on specified days
干预措施: Placebo (Drug)
Arm A
Experimental
Specified dose on specified days
干预措施: BMS-986224 (Drug)
Arm B
Placebo Comparator
Specified dose on specified days
干预措施: Placebo (Drug)
Arm B
Placebo Comparator
Specified dose on specified days
干预措施: BMS-986224 (Drug)
结局指标
主要结局
Number of Adverse Events (AEs)
时间窗: Up to one month
Number of Serious Adverse Events (SAEs)
时间窗: Up to one month
Number of deaths
时间窗: Up to one month
次要结局
- Maximum observed plasma concentration (Cmax)(Up to one month)
- Time of maximum observed plasma concentration (Tmax)(Up to one month)
- Terminal elimination half-life (T-HALF)(Up to one month)
- Ratio of Metabolite AUC(INF) to Parent AUC(INF), corrected for molecular weight(Up to one month)
- Accumulation ratio: ratio of AUC(TAU) following last dose to AUC(TAU) following first dose (ARtau)(Up to one month)
- Apparent oral clearance, calculated as dose/AUC(INF) for single dose or dose/AUC(TAU) for multiple dose(Up to one month)
- Cumulative urinary excretion (of the unchanged drug) [Aet](Up to one month)
- Ratio of Metabolite AUC(TAU) to Parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)](Up to one month)
- Area under the plasma concentration-time curve from time zero extrapoloated [AUC(INF)](Up to one month)
- Apparent volume of distribution at terminal phase (Vz/F)(Up to one month)
- Cumulative urinary excretion (of the unchanged drug) over one dosing interval [Ae(TAU)](Up to one month)
- Renal clearance (CLr)(Up to one month)
- Area under the concentration-time curve in one dosing interval [AUC(TAU)](Up to one month)
- Accumulation ratio: ratio of Cmax following last dose to Cmax following first dose (ARcmax)(Up to one month)
- Terminal elimination rate constant (kel)(Up to one month)
- Amount excreted unchanged (%) [UR%](Up to one month)
- Ratio of Metabolite Cmax to Parent Cmax, corrected for molecular weight (MR_Cmax)(Up to one month)
- Drug-drug interaction (DDI) assessment(Up to one month)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)](Up to one month)
- Ratio of Metabolite AUC(0-T) to Parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)](Up to one month)
研究者
研究点 (18)
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