NCT02208882已完成1 期
Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of BMS-986120 in Healthy Subjects and the Effect of BMS-986120 on the Pharmacokinetics of Midazolam in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年8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
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[Height(m)]2
- •Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive
排除标准
- •Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
- •Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:
- •i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
- •ii) Total bilirubin >ULN, thyroid-stimulating hormone (TSH) >1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)
- •iii) CK >3 x ULN (unless exercise related and CK-MB within normal limits)
- •iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) >ULN
- •v) Blood urea nitrogen (BUN) or creatinine (Cr) >ULN
- •Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)
- •Bleeding time exceeding 8 minutes at pre-dose on Day -1
- •Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any major surgery within 12 weeks of study drug administration
研究组 & 干预措施
Panel 1: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: BMS-986120 (Drug)
Panel 1: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: Placebo (Drug)
Panel 2: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: BMS-986120 (Drug)
Panel 2: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: Placebo (Drug)
Panel 3: BMS-986120 or Placebo + Midazolam
Experimental
BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified
干预措施: BMS-986120 (Drug)
Panel 3: BMS-986120 or Placebo + Midazolam
Experimental
BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified
干预措施: Placebo (Drug)
Panel 3: BMS-986120 or Placebo + Midazolam
Experimental
BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified
干预措施: Midazolam (Drug)
Panel 4: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: BMS-986120 (Drug)
Panel 4: BMS-986120 or Placebo
Experimental
BMS-986120 or Placebo multiple dose by mouth as specified
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
时间窗: Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
时间窗: Up to 168 days
次要结局
- Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Half-life (T-HALF) of BMS-986120 and BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120(Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22))
- Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120(Part A (Days 1-3) & Part B/C (Days 1-19))
研究者
研究点 (1)
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