An Open-Label Single-Sequence Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-Dose Pharmacokinetics of BMS-986177 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of BMS-986177
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 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 determinations.
- •Subjects with body mass index of 18 to 30 kg/m2, inclusive
- •Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and are not breast feeding
- •Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 92 days for subjects in the BMS-986177 - diltiazem sequence, and 99 days for subjects in the BMS-986177 - itraconazole sequence.
排除标准
- •Any significant acute or chronic medical illness, including hepatic disease, or any other condition listed as a contraindication in the diltiazem or itraconazole package inserts.
- •Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation.
- •History of chronic constipation, GI disease, arrhythmias, sinus bradycardia, significant head injury, dizziness or headaches, hemophilia, Rosenthal syndrome, or FX1a deficiency or other coagulopathies, systemic lupus erythematosus.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- •History of allergy to BMS-986177, itraconazole, diltiazem, or related compounds.
研究组 & 干预措施
BMS-986177 and Itraconazole
Single dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days
干预措施: BMS-986177 (Drug)
BMS-986177 and Itraconazole
Single dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days
干预措施: Itraconazole (Drug)
BMS-986177 and Diltiazem
Single dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days
干预措施: BMS-986177 (Drug)
BMS-986177 and Diltiazem
Single dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days
干预措施: Diltiazem ER (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Days 1-12
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Days 1-12
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) of BMS-986177
时间窗: Days 1-12
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 scheduled visit occurs at a later time.)