A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of BMS-626529
研究概览
简要总结
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Males and females, 18 to 50 years of age, inclusive
- •Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- •Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
排除标准
- •Any significant acute or chronic medical illness
- •Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- •Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
- •i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
- •Exposure to any investigational drug or placebo within 12 weeks of study drug administration
- •Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
研究组 & 干预措施
Part 1
BMS-663068 1 × 600 mg extended-release (ER) tablet formulation
干预措施: BMS-663068 (Drug)
Part 1: Prototype 1
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)
干预措施: BMS-663068 (Drug)
Part 1: Prototype 2
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)
干预措施: BMS-663068 (Drug)
Part 1: Prototype 3
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)
干预措施: BMS-663068 (Drug)
Part 1: Prototype 4
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)
干预措施: BMS-663068 (Drug)
Part 1: Prototype 5
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)
干预措施: BMS-663068 (Drug)
Part 2
BMS-663068 1 × 600 mg ER tablet formulation
干预措施: BMS-663068 (Drug)
Part 2: Prototype 1
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)
干预措施: BMS-663068 (Drug)
Part 2: Prototype 4
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)
干预措施: BMS-663068 (Drug)
Part 2: Prototype 2
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)
干预措施: BMS-663068 (Drug)
Part 2: Prototype 3
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)
干预措施: BMS-663068 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of BMS-626529
时间窗: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529
时间窗: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529
时间窗: Day 1 to Day 4 of each period
次要结局
- Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs(Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing)
- Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE)(Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing)