A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
研究概览
简要总结
This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- •Males and females must agree to follow specific methods of contraception, if applicable.
- •Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.
排除标准
- •Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
- •Inability to tolerate oral medication
- •Known previous exposure to BMS-
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B: BMS-986235+ Bupropion
干预措施: Bupropion (Drug)
Arm A: BMS-986235+Fluconazole
干预措施: Fluconazole (Drug)
Arm A: BMS-986235+Fluconazole
干预措施: BMS-986235 (Drug)
Arm B: BMS-986235+ Bupropion
干预措施: BMS-986235 (Drug)
Arm C: BMS-986235+ Itraconazole
干预措施: Itraconazole (Drug)
Arm C: BMS-986235+ Itraconazole
干预措施: BMS-986235 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
时间窗: Day 9
Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
时间窗: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
时间窗: Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
时间窗: Day 13
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
时间窗: Day 12
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
时间窗: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
时间窗: Day 12
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
时间窗: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
时间窗: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
时间窗: Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
时间窗: Day 1
Maximum plasma concentration (Cmax) of BMS-986235
时间窗: Day 1
次要结局
- Incidence of Nonserious Adverse Events (AEs)(Up to 49 days)
- Incidence of AEs leading to discontinuation(Up to 16 days)
- Number of clinically significant changes from baseline in vital signs: Body Temperature(Up to 44 days)
- Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry(Up to 44 days)
- Number of clinically significant changes in clinical laboratory tests: Urinalysis(Up to 44 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 77 days)
- Number of clinically significant changes in clinical laboratory tests: Hematology(Up to 44 days)
- Number of clinically significant changes in clinical laboratory tests: Coagulation(Up to 44 days)
- Number of clinically significant changes from baseline in vital signs: Heart Rate(Up to 44 days)
- Number of clinically significant changes in electrocardiogram (ECG)(Up to 44 days)
- Number of clinically significant changes from baseline in physical examinations(Up to 44 days)
- Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))(Up to 44 days)
- Number of clinically significant changes from baseline in vital signs: Respiratory Rate(Up to 44 days)
- Number of clinically significant changes from baseline in vital signs:Blood Pressure(Up to 44 days)