NCT00608699已完成1 期
A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
研究概览
简要总结
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males between 18 and 55 years of age, inclusive.
- •Healthy subjects
- •Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
- •Subjects with QTc < 450 msec at screening
排除标准
- •History of significant cardiac arrhythmias
- •Active peptic ulcer disease (PUD) and/or history of PUD
- •History of gout and/or hyperuricemia
- •History of Gilbert's syndrome
- •History of recurrent indigestion, stomach upset or diarrhea
- •History of other than rare (once yearly or less) flushing
- •Recurrent skin rash or psoriasis
- •History of kidney stones
结局指标
主要结局
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
时间窗: up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin
时间窗: up to 36 hours post dose
次要结局
- Standard and Secondary pharmacokinetic endpoints of interest(up to 36 hours post dose)
- Pharmacodynamic response(up to 24 hours post dose)
研究者
研究点 (2)
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