NCT00721812已完成1 期
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design
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
- 87
- 试验地点
- 1
- 主要终点
- • Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles
研究概览
简要总结
A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A
Other
Single dose escalation
干预措施: GSK1399686 (Drug)
Part B
Other
14 day repeat dose escalation
干预措施: GSK1399686 (Drug)
Part C
Other
Fixed dose food effect
干预措施: GSK1399686 (Drug)
结局指标
主要结局
• Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles
时间窗: 72 hours and 14 days
次要结局
- PK parameters per protocol(72 hours and 14 days)
研究者
研究点 (1)
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