NCT00730990已完成1 期
A8801007 A Phase I, Healthy Volunteer Qualification Of Ligand [C 11] PF 04621053 And Randomized Determination Of H3 Receptor Occupancy Of PF 03654746, Using PET
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
- 10
- 试验地点
- 1
- 主要终点
- Overall H3 Receptor Occupancy of PF 03654746.
研究概览
简要总结
The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at the H3 receptor after a single oral dose of PF 03654746.
详细描述
Additional Study Purpose Details: To validate PET ligand which will be used to determine receptor occupancy and to determine receptor occupancy of PF-0367456
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects 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).
- •Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI at the lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •History of febrile illness within 5 days prior to the first dose.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen at Screening or Day
- •History of regular alcohol consumption exceeding 14 drinks/week for men (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.
- •Positive cotinine screen at Screening or Day
- •Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication (excluding [C-11]PF-04621053).
- •12-lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
- •Chronic (every day) use of a histamine (H1, H2) inhibitor(s) within 3 months before screening.
研究组 & 干预措施
Cohort 1
Experimental
This arm will have no active treatment.
干预措施: Positron Emission tomography (Other)
Cohort 2
Experimental
干预措施: PET Scan with PF-03654746 (Drug)
结局指标
主要结局
Overall H3 Receptor Occupancy of PF 03654746.
时间窗: 48 hours
次要结局
- Binding potential (BP) of [C-11]PF 04621053.(48 hours)
- Relationship between serum PF 03654746 concentration and H3 RO (IC50).(48 hours)
- H3 RO of PF 03654746 at regions of interest in man(48 hours)
研究者
研究点 (1)
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