A Phase 1, 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Itraconazole, Food, and pH, on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) to 33.0 kg/m^2, inclusive.
排除标准
- •Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
- •Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- •Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: BMS-986368 with Itraconazole - Fasted
干预措施: Itraconazole (Drug)
Part 1: BMS-986368 - Fasted
干预措施: BMS-986368 (Drug)
Part 1: Itraconazole - Fasted
干预措施: Itraconazole (Drug)
Part 1: BMS-986368 with Itraconazole - Fasted
干预措施: BMS-986368 (Drug)
Part 2: BMS-986368 - Fasted
干预措施: BMS-986368 (Drug)
Part 2: BMS-986368 - Fed
干预措施: BMS-986368 (Drug)
Part 2: Famotidine, followed by BMS-986368 - Fasted
干预措施: BMS-986368 (Drug)
Part 2: Famotidine, followed by BMS-986368 - Fasted
干预措施: Famotidine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 11 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to 11 days
次要结局
- Number of participants with adverse events (AEs)(Up to 41 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 17 days)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 17 days)
- Number of participants with physical examination abnormalities(Up to 17 days)
- Number of participants with vital sign abnormalities(Up to 17 days)
- Number of participants with clinical laboratory abnormalities(Up to 17 days)