NCT03044873已完成1 期
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年2月2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
- 20
- 试验地点
- 1
- 主要终点
- Cmax (Maximum observed plasma concentration) of Rosuvastatin.
研究概览
简要总结
The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Healthy male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- •Subjects with body mass index of 18 to 32 kg/m2, inclusive.
- •Women participants must have documented proof that they are not of childbearing potential.
- •Men who are sexually active with WOCBP must agree to follow instructions for method(s) of highly effective contraception for the duration of study treatment(s) plus 5 half-lives of BMS-986165 (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days of post BMS-986165 treatment. In addition, male participants must be willing to refrain from sperm donation during this time.
排除标准
- •History of allergy to BMS-986165, rosuvastatin, or related compounds, of myalgia or rhabdomyolysis while taking rosuvastatin or related compounds or any other drug allergy
- •Any significant acute or chronic medical illness, active TB requiring treatment or documented latent TB within the previous 3 years, current or recent gastrointestinal disease, current or recent history of nausea, vomiting, constipation or irregular bowel movement
- •History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
- •Smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4 weeks of study treatment administration, current skin findings that could interfere with the interpretation of study
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS 986165 and Rosuvastatin
Experimental
干预措施: Rosuvastatin (Drug)
BMS 986165 and Rosuvastatin
Experimental
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Cmax (Maximum observed plasma concentration) of Rosuvastatin.
时间窗: Up to Day 13
Measured by plasma concentration.
AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin.
时间窗: Up to Day 13
Measured by plasma concentration.
AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.
时间窗: Up to Day 13
Measured by plasma concentration.
次要结局
- Number of Subjects with Deaths.(Up till 30 days after discontinuation)
- Number of Subjects with Serious Adverse Events.(Up till 30 days after discontinuation)
- Number of Subjects with Adverse Events.(Up till 30 days after discontinuation)
- Number of subjects with Adverse Events Leading to Discontinuation.(Up till 30 days after discontinuation)
研究者
研究点 (1)
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