NCT04949269已完成1 期
A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年7月20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
- 61
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
研究概览
简要总结
The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
- •Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).
排除标准
- •Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
- •Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- •Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A
Experimental
干预措施: Deucravacitinib (Drug)
Part B
Experimental
干预措施: Deucravacitinib (Drug)
Part C
Experimental
干预措施: Deucravacitinib (Drug)
Part C
Experimental
干预措施: Famotidine (Drug)
Part D
Experimental
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
时间窗: Up to 7 days
Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib
时间窗: Up to 7 days
Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib
时间窗: Up to 7 days
次要结局
- Incidence of non-serious Adverse Events (AEs)(Up to 18 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 30 days post discontinuation of dosing or participant's participation in the study)
- Incidence of clinically significant changes in clinical laboratory values: Chemistry tests(Up to 11 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 11 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 11 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Up to 11 days)
- Incidence of clinically significant changes in ECG parameters: QT interval(Up to 11 days)
- Incidence of clinically significant changes in ECG parameters: QTcF(Up to 11 days)
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests(Up to 11 days)
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests(Up to 11 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 11 days)
- Incidence of clinically significant changes in ECG parameters: QRS(Up to 11 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 11 days)
研究者
研究点 (2)
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