NCT00939887终止1 期
A Phase 1, Healthy Volunteer Qualification Of Ligand [11C] PF-04767135 And Randomized Determination Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall kappa opioid receptor occupancy of PF 04455242.
研究概览
简要总结
This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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 non-childbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically 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.)
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen at Screening or Day
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.
- •Use of tobacco- or nicotine-containing products within 3 months of screening.
- •Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication (excluding [11C]PF 04767135).
- •12 lead ECG demonstrating QTc >450 msec at Screening.
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Treatment
Experimental
干预措施: PF-04455242 (Drug)
结局指标
主要结局
Overall kappa opioid receptor occupancy of PF 04455242.
时间窗: Study Day 1 and 2
次要结局
- Binding potential (BP) of [11C] PF 04767135.(Study Day 1 and 2)
- Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man.(Study Day 1 and 2)
- Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50).(Study Day 1 and 2)
研究者
研究点 (1)
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