NCT01396252已完成1 期
Randomized, Placebo-Controlled, Double-Blind, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Japanese Subjects and Japanese Patients With Depression
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011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
- 57
- 试验地点
- 1
- 主要终点
- Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.
排除标准
- •Any significant acute or chronic medical illness.
- •Non-compliance, or overall not suitable as determined by the investigator.
- •History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.
研究组 & 干预措施
Arm1: BMS-820836
Experimental
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
干预措施: BMS-820836 (Drug)
Arm 2: Placebo matching BMS-820836
Placebo Comparator
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
干预措施: Placebo matching BMS-820836 (Drug)
结局指标
主要结局
Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Day 1 through Day 33
次要结局
- Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007(Day1 through Day 33)
- Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)(Day1 through Day 33)
- ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals)(Day1 through Day 33)
- Vital sign measures (heart rate and blood pressure) and the orthostatic changes(Day1 through Day 33)
研究者
研究点 (1)
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