A Phase I, Randomized, Placebo Controlled, Parallel Group, Single Dose Study To Evaluate The Effects Of PF-00572778 And Alprazolam On A Naloxone Challenge In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
研究概览
简要总结
PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors. Demonstration of a statistically significant attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound. Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following naloxone challenge in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy male and/or female subjects between the ages of 18 and 45 years; Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Family (1st degree relatives) and personal history of meeting Diagnostic and Statistical Manual -IV (DSM-IV) criteria for alcohol abuse or dependence.
研究组 & 干预措施
1
干预措施: alprazolam (Drug)
2
干预措施: Placebo (Other)
3
干预措施: PF-00572778 (Drug)
结局指标
主要结局
Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
时间窗: 1st day on treatment
次要结局
- Maximum observed serum concentration (Cmax)(1st day on treatment)
- Time to reach the maximum observed serum concentration (Tmax)(1st day on treatment)
- Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations(34 days (weekly))
- Peak concentrations for plasma cortisol and ACTH(1st day on treatment)
- Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast)(2nd day on treatment (Days 6-7))
- Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge(1st day on treatment)