A 2 Part Open-label, Randomised, Crossover Study to Compare the Effects of Formulation, Food and Particle Size on the Pharmacokinetic Profiles of a Single 175mg Dose of GW842166X in Healthy Male and Female Volunteers

GlaxoSmithKline0 个研究点开始时间: 2007年9月最近更新: 2015年2月16日

适应症

试验速览

阶段: 1 期
状态: 撤回
发起方: GlaxoSmithKline
主要终点: Plasma GW842166 Cmax and AUC (O-Infinity)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female 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: None

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
•Healthy as judged by a responsible physician.

排除标准

•Positive pre-study urine screen for drugs of abuse or alcohol breath test.

结局指标

主要结局

Plasma GW842166 Cmax and AUC (O-Infinity)

时间窗: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)

次要结局

Plasma GW842166 AUC (0-t), tlag,tmax and t1/2(Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose))

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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