NCT00791817已完成1 期
An Open-label, Single Dose, Randomized, Crossover Study to Evaluate Potential Food Effects
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
详细描述
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
- •Who have not used tobacco or nicotine-containing products within the past 3 months;
- •Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
- •Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
排除标准
- •History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- •History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
- •History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
- •History of autoimmune disease;
- •History of immunodeficiency or of unusual susceptibility to infectious diseases;
- •History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
- •Any history of hypersensitivity or clinically significant allergy to any drug;
- •Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
- •Family history of sudden death;
- •History of uveitis or inflammatory ocular disease;
- •History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
- •History of autoimmune disease;
- •History of immunodeficiency or of unusual susceptibility to infectious diseases;
- •History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
- •Any history of hypersensitivity or clinically significant allergy to any drug;
- •Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
- •Family history of sudden death;
- •History of uveitis or inflammatory ocular disease.
研究组 & 干预措施
200 mg PG 760564, Subjects Fed
Experimental
200 mg PG 760564, Subjects Fed high fat meal
干预措施: PG-760564 (Drug)
200 mg PG 760564, Subjects Fasted
Experimental
200 mg PG 760564, Subjects Fasted, single dose
干预措施: PG-760564 (Drug)
结局指标
主要结局
Cmax
时间窗: over 12 hours
Maximum plasma concentration after a single dose
次要结局
未报告次要终点
研究者
研究点 (1)
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