NCT01467726已完成1 期
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tolerability of repeat dosing of velusetrag
研究概览
简要总结
This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.
- •Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study.
- •Mild deviations from normal limits in PE, VS, ECG parameters, lab tests are acceptable if associated with the stable condition or are age-related
排除标准
- •Has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or PK or PD of the investigational drug, or prevent compliance with the protocol
研究组 & 干预措施
Dose regimen 1
Experimental
Varied doses
干预措施: Velusetrag (Drug)
Dose regimen 2
Experimental
Varied doses
干预措施: Velusetrag (Drug)
Placebo
Experimental
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerability of repeat dosing of velusetrag
时间窗: 3 weeks
Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs
次要结局
- Pharmacodynamic effects of velusetrag(3 weeks)
- Profile of urine PK of velusetrag and metabolite(Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose)
- Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite(Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose))
研究者
研究点 (1)
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