NCT04965389已完成1 期
A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年7月16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
- 17
- 试验地点
- 1
- 主要终点
- Absolute Bioavailability (F)
研究概览
简要总结
The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height [m])²
排除标准
- •History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months, intracranial bleeding, tumor, aneurysms
- •History or evidence of abnormal bleeding or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such as epistaxis, or family history of coagulopathies
- •Any acute or chronic medical illness considered clinically significant by the investigator
- •History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment Sequence 1
Experimental
干预措施: BMS-986177 Oral Solution (Drug)
Treatment Sequence 1
Experimental
干预措施: [14C]BMS-986177 Solution for Infusion (Drug)
Treatment Sequence 1
Experimental
干预措施: BMS-986177 Spray-dried Dispersion Capsules (Drug)
Treatment Sequence 2
Experimental
干预措施: BMS-986177 Oral Solution (Drug)
Treatment Sequence 2
Experimental
干预措施: [14C]BMS-986177 Solution for Infusion (Drug)
Treatment Sequence 2
Experimental
干预措施: BMS-986177 Spray-dried Dispersion Capsules (Drug)
Treatment Sequence 3
Experimental
干预措施: BMS-986177 Oral Solution (Drug)
Treatment Sequence 3
Experimental
干预措施: [14C]BMS-986177 Solution for Infusion (Drug)
Treatment Sequence 3
Experimental
干预措施: BMS-986177 Spray-dried Dispersion Capsules (Drug)
Treatment Sequence 4
Experimental
干预措施: BMS-986177 Oral Solution (Drug)
Treatment Sequence 4
Experimental
干预措施: [14C]BMS-986177 Solution for Infusion (Drug)
Treatment Sequence 4
Experimental
干预措施: BMS-986177 Spray-dried Dispersion Capsules (Drug)
结局指标
主要结局
Absolute Bioavailability (F)
时间窗: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).
次要结局
- Number of Participants Experiencing Serious Adverse Events (SAE)(Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks))
- Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(INF)](Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Total Amount of Unchanged Drug Excreted Into the Urine (Ae)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Total Percent Urinary Recovery (%UR)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)](Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Number of Participants With Abnormal Electrocardiograms (ECGs)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Time of Maximum Observed Plasma Concentration (Tmax)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Renal Clearance (CLR)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Number of Participants Experiencing Abnormal Vital Sign Measurements(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Number of Participants With Abnormal Physical Examinations(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Maximum Observed Plasma Concentration (Cmax)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Apparent Clearance of Drug After Extravascular Administration (CLT/F)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Volume of Distribution at Steady State (Vss) Following an IV Dose in Treatment A(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Relative Bioavailability (Frel) Based on Ratios of Cmax(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Relative Bioavailability (Frel) Based on Ratios of AUC(0-T) and AUC(INF)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Number of Participants Experiencing Adverse Events (AEs)(Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks))
- Number of Participants With Clinical Laboratory Test Abnormalities(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Half-life (T-HALF)(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Mean Residence Time (MRT) Following an IV Dose in Treatment A(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Food Effect Based on Ratios of AUC(0-T) and AUC(INF) Following an SDD Capsule Dose in Treatment B, C, D, and E(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
- Food Effect Based on Ratios of Cmax Following an SDD Capsule Dose in Treatment B, C, D, and E(Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks))
研究者
研究点 (1)
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