NCT00827515撤回1 期
A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Blood levels of PH797804 up to 336 hours after dosing in each treatment period
研究概览
简要总结
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged 21 to 55 years
- •Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
- •Willing to use acceptable methods of contraception as outlined in the study protocol
- •Body mass index between 18 to 30 kg/m2
- •Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures
排除标准
- •Subjects with evidence or history of clinically significant disease
- •Pregnant or nursing females
- •Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
- •Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
- •A positive approved immunoassay/ELISA blood test for TB
- •Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
- •Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- •Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
研究组 & 干预措施
One
Experimental
干预措施: PH797804 (Drug)
Two
Experimental
干预措施: PH797804 (Drug)
Three
Experimental
干预措施: PH797804 (Drug)
Four
Experimental
干预措施: PH797804 (Drug)
结局指标
主要结局
Blood levels of PH797804 up to 336 hours after dosing in each treatment period
时间窗: 336 hours
次要结局
- Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose(336 hours)
研究者
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