NCT01173757已完成1 期
A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.
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
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Exposure response of overall 5HT4 receptor occupancy of PF-04995274
研究概览
简要总结
The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
- •Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
研究组 & 干预措施
PF-04995274
Experimental
干预措施: PF-04995274 (Drug)
结局指标
主要结局
Exposure response of overall 5HT4 receptor occupancy of PF-04995274
时间窗: up to 3 days
5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain
时间窗: up to 3 days
次要结局
- Clinical examinations(up to 3 days)
- change from baseline in vital signs(up to 3 days)
- Singlet ECG post-dose(up to 3 days)
- Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma(up to 3 days)
- Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma(up to 3 days)
- Adverse events(up to 3 days)
- Clinical safety laboratory endpoints(up to 3 days)
研究者
研究点 (1)
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