NCT02912234已完成1 期
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月最近更新:
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
- Maximum observed concentration (Cmax)
研究概览
简要总结
This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Target population: Healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
- •Subjects with body mass index of 18 to 30 kg/m2, inclusive
- •Women must not be breast feeding, have a negative serum or urine pregnancy test and must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of study treatments apixaban and clarithromycin plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.
- •Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of the study treatment plus 30 days for a total of 33 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
排除标准
- •History of any significant medical illness, drug allergy including allergy to apixaban, FXa inhibitors (and/or their excipients), clarithromycin, macrolides, and/or related compounds. History of substance abuse and use of nicotine containing products and/or alcohol abuse.
- •History of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, including hypermenorrhea, intra-cranial hemorrhage, family history of bleeding disorders in first degree relatives, and/or any adverse reaction to anticoagulants or antiplatelet agents that resulted in excessive bleeding.
- •History of recurrent neurological or gastrointestinal disorders, including insomnia, chronic headaches, dizziness, gastroesophageal reflux disease, cholecystectomy, gastric ulcers and/or Gilbert's syndrome.
- •History of antibiotic induced secondary infections, including candidiasis.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory tests beyond what is consistent with the target population.
研究组 & 干预措施
Apixaban and Clarithromycin
Experimental
干预措施: Apixaban (Drug)
Apixaban and Clarithromycin
Experimental
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Days 1-11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Days 1-11
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Days 1-11
次要结局
- Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death(Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last)
研究者
研究点 (1)
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