NCT04263350已完成1 期
An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年2月26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
- 34
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
研究概览
简要总结
The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- •Women and men must agree to follow specific methods of contraception, if applicable.
排除标准
- •History of a clinically significant drug rash or Stevens-Johnson Syndrome
- •History of Gilbert's Syndrome
- •Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
- •Any major surgery within 4 weeks of study treatment administration
- •Any gastrointestinal surgery that could impact upon the absorption of study treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment A:Fixed- dose combination mini-tablet
Experimental
干预措施: Atazanavir/Cobicistat (Drug)
Treatment B: Separate products taken at the same time
Experimental
干预措施: Reyataz Atazanavir (Drug)
Treatment B: Separate products taken at the same time
Experimental
干预措施: Cobicistat (Drug)
结局指标
主要结局
Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
时间窗: Up to Day 10
Cmax of Cobicistat (COBI)
时间窗: Up to Day 10
Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)
时间窗: Up to Day 10
AUC(INF) of COBI
时间窗: Up to Day 10
次要结局
- Incidence of AEs leading to discontinuation(Up to 40 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 70 days)
- Incidence of deaths(Up to 40 days)
- Incidence of marked abnormalities in vital sign measurements: Blood Pressure(Up to 40 days)
- Marked abnormalities in clinical laboratory test results(Up to 40 days)
- Incidence of marked abnormalities in vital sign measurements: Heart Rate(Up to 40 days)
- Incidence of marked abnormalities in Electrocardiogram (ECG) recording(Up to 40 days)
- Incidence of Palatability questionnaire results(Up to 40 days)
研究者
研究点 (1)
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