NCT05901714已完成1 期
An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年6月14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
- 65
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
研究概览
简要总结
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
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
- •Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.
排除标准
- •Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.
- •History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.
- •Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: Afimetoran followed by phenytoin + afimetoran
Experimental
干预措施: Afimetoran (Drug)
Part 1: Afimetoran followed by phenytoin + afimetoran
Experimental
干预措施: Phenytoin (Drug)
Part 2: Midazolam followed by afimetoran + midazolam
Experimental
干预措施: Afimetoran (Drug)
Part 2: Midazolam followed by afimetoran + midazolam
Experimental
干预措施: Midazolam (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to 53 days
Parts 1 and 2
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to 53 days
Parts 1 and 2
Maximum observed plasma concentration (Cmax)
时间窗: Up to 53 days
Parts 1 and 2
次要结局
- Number of participants with clinical laboratory abnormalities(Up to 66 days)
- Number of participants with vital sign abnormalities(Up to 66 days)
- Time to attain maximum observed plasma concentration (Tmax)(Up to 53 days)
- Number of participants with adverse events (AEs)(Up to 124 days)
- Apparent total body clearance of the drug from the plasma (CLT/F)(Up to 53 days)
- Number of participants with physical examination abnormalities(Up to 66 days)
- Terminal half-life (T-Half)(Up to 53 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 66 days)
研究者
研究点 (1)
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