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
概览
- 阶段
- 1 期
- 干预措施
- BMS-820836
- 疾病 / 适应症
- Depression
- 发起方
- Bristol-Myers Squibb
- 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)
- 状态
- 已完成
- 最后更新
- 12年前
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.
研究者
入排标准
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
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
Arm 2: Placebo matching BMS-820836
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
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)