NCT05389722已完成1 期
A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月9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
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Must have a body mass index between 18 and 33 kg/m2 (inclusive)
- •Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments
排除标准
- •Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
- •Any major surgery within 4 weeks of the first dose administration
- •History of drug abuse within 2 years of the first dose administration
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1
Experimental
干预措施: CC-92480 (Drug)
Part 1
Experimental
干预措施: Rifampin (Drug)
Part 2
Experimental
干预措施: CC-92480 (Drug)
Part 2
Experimental
干预措施: Itraconazole (Drug)
Part 3
Experimental
干预措施: CC-92480 (Drug)
Part 3
Experimental
干预措施: Digoxin (Drug)
Part 3
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 2 months
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Up to 2 months
次要结局
- Number of participants with adverse events (AEs)(Up to 3 months)
- Number of participants with physical examination findings(Up to 3 months)
- Number of participants with vital sign abnormalities(Up to 3 months)
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to 3 months)
- Number of participants with clinical laboratory abnormalities(Up to 3 months)
研究者
研究点 (1)
Loading locations...
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