A Phase 1, Open-label, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Part A: Cmax of BMS-986365 Without Itraconazole
研究概览
简要总结
The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.
排除标准
- •Participants must not have any significant or chronic illness.
- •Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part A (Safety Lead-in Group)
干预措施: BMS-986365 (Drug)
Part A (Safety Lead-in Group)
干预措施: Itraconazole (Drug)
Part A, Period 1
干预措施: BMS-986365 (Drug)
Part A, Period 2
干预措施: BMS-986365 (Drug)
Part A, Period 2
干预措施: Itraconazole (Drug)
Part B, Period 1
干预措施: BMS-986365 (Drug)
Part B, Period 2
干预措施: BMS-986365 (Drug)
Part B, Period 2
干预措施: Rifampin (Drug)
结局指标
主要结局
Part A: Cmax of BMS-986365 Without Itraconazole
时间窗: Up to approximately Day 32
Part A: AUC(INF) of BMS-986365 Without Itraconazole
时间窗: Up to approximately Day 32
Part B: Cmax of BMS-986365 Without Rifampin
时间窗: Up to approximately Day 37
Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365
时间窗: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole
时间窗: Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365
时间窗: Up to approximately Day 32
Part B: Cmax of BMS-986365 With Rifampin
时间窗: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 Without Rifampin
时间窗: Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 Without Rifampin
时间窗: Up to approximately Day 37
Part A: AUC(0-T) of BMS-986365 Without Itraconazole
时间窗: Up to approximately Day 32
Part B: AUC(0-T) of BMS-986365 With Rifampin
时间窗: Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 With Rifampin
时间窗: Up to approximately Day 37
次要结局
- Number of Participants With Adverse Events (AEs)(Up to approximately Day 89)
- Number of Participants With Serious Adverse Events (SAEs)(Up to approximately Day 89)
- Number of Participants With AEs Leading to Drug/Study Discontinuation(Up to approximately Day 89)
- Number of Participants With Clinically Significant Vital Sign Measurements(Up to approximately Day 77)
- Number of Participants With Clinically Significant Laboratory Safety Tests(Up to approximately Day 77)
- Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities(Up to approximately Day 77)
- Part A: Change From Baseline of QTc Post Dose of BMS-986365 With Itaconazole(Up to approximately Day 72)
- Part B: Change From Baseline of QTc Post Dose of BMS-986365 With Rifampin(Up to approximately Day 77)
- Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986365(Up to approximately Day 77)
- Apparent Terminal Plasma Half-life (T-HALF) of BMS-986365(Up to approximately Day 77)
- Apparent Total Body Clearance (CLT/F) of BMS-986365(Up to approximately Day 77)
- Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities(Up to approximately Day 77)
- Change From Baseline of Corrected QT Interval (QTc) Post Dose of BMS-986365(Up to approximately Day 77)
- Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986365(Up to approximately Day 77)