NCT06566768已完成1 期
A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Oral Gastro-retentive Tablet Formulation Prototypes in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年10月7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
- 52
- 试验地点
- 1
- 主要终点
- Concentration at 24 hours post dose (C24)
研究概览
简要总结
The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 males and healthy females according to the assessment of the Investigator.
- •Body mass index of 18.0 kg/m^2 through 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg.
排除标准
- •Any significant acute or chronic medical illness.
- •Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion.
- •History of any significant drug allergy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part A: Deucravacitinib
Experimental
干预措施: Deucravacitinib (Drug)
Part B: Deucravacitinib
Experimental
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Concentration at 24 hours post dose (C24)
时间窗: Up to approximately 5 days
Maximum observed plasma concentration (Cmax)
时间窗: Up to approximately 5 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to approximately 5 days
次要结局
- Incidence of participants with vital sign abnormalities(Up to approximately 1 month)
- Time of maximum observed concentration (Tmax)(Up to approximately 5 days)
- Incidence of AEs leading to discontinuation(Up to approximately 1 month)
- Incidence of adverse events (AEs)(Up to approximately 1 month)
- Apparent terminal plasma half-life (T-HALF)(Up to approximately 5 days)
- Incidence of serious adverse events (SAEs)(Up to approximately 1 month)
- Incidence of participants with physical examinations abnormalities(Up to approximately 1 month)
- Incidence of participants with electrocardiogram (ECG) abnormalities(Up to approximately 1 month)
- Incidence of participants with clinical laboratory abnormalities(Up to approximately 1 month)
- Apparent total body clearance (CLT/F)(Up to approximately 5 days)
研究者
研究点 (1)
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