NCT03950960已完成1 期
An Open-label, Single-Sequence, 2-Treatment Period Study to Investigate the Effects of Cytochrome P450 3A4 Inhibition by Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of BMS-986256
研究概览
简要总结
The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the Investigator would compromise the conduct, results, or interpretation of the study findings
- •A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months of the screening visit
- •Weight greater than or equal to (>=) 50 kilogram (kg) and body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2) inclusive at screening
排除标准
- •Prior exposure to BMS-986256
- •Previous investigational drug or placebo exposure within 6 weeks before nonbiologic study drug administration or 12 weeks before biologic study drug administration
- •History or presence of malignancy including hematological malignancies. However, participants with a history of basal cell or squamous cell carcinoma that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986256 +Itraconazole
Experimental
干预措施: BMS-986256 (Drug)
BMS-986256 +Itraconazole
Experimental
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of BMS-986256
时间窗: After single dose on Days 1 and 29
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256
时间窗: After single dose on Days 1 and 29
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256
时间窗: After single dose on Days 1 and 29
次要结局
- Percentage of Participants with Adverse Events (AEs)(From the time of study treatment administration through the final study visit (Up to 55 days))
- Percentage of Participants with Serious Adverse Events (SAEs)(From the time ICF is signed through 30 days post dose, or the final study visit (Up to 60 days))
- Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities(From screening to follow-up (Up to 55 days))
研究者
研究点 (1)
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