NCT02349607已完成1 期
A Double Blind, Double Dummy, Randomized, Placebo-controlled, 5 Period Cross-over Study To Examine The Effect Of Pf-05089771 Alone And In Combination With Pregabalin On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls
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
- 25
- 试验地点
- 1
- 主要终点
- Thermal pain detection threshold
研究概览
简要总结
This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
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
- Double (Participant, Investigator)
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 or clinical laboratory tests. •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. •Subjects who are willing and able to comply with all 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). •Any condition possibly affecting drug absorption (eg, gastrectomy). •A positive urine drug screen
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PF-05089771 300 mg
Experimental
干预措施: PF-05089771 300mg (Drug)
PF-05089771 300 mg + pregabalin 300 mg
Experimental
干预措施: PF-05089771 300 mg + pregabalin 300 mg (Drug)
pregabalin 300 mg
Active Comparator
干预措施: pregabalin 300 mg (Drug)
ibuprofen 600 mg
Active Comparator
干预措施: ibuprofen 600 mg (Drug)
结局指标
主要结局
Thermal pain detection threshold
时间窗: 1-10 hours
Ultra-violet light sensitized pain detection threshold
时间窗: 1-10 hours
Electrical pain tolerance threshold
时间窗: 1-10 hours
Pressure pain tolerance threshold
时间窗: 1-10 hours
Cold pressor tolerance threshold
时间窗: 1-10 hours
次要结局
- Electrical pain detection threshold(0.5-10 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0.5-10)
- Electrical pain post test visual analogue scale(0.5-10 hours)
- Pressure pain area under the visual analogue scale curve(0.5-10 hours)
- Conditioned pain modulation area under the visual analogue scale curve(0.5-10 hours)
- Condition pain modulation post test VAS(0.5-10 hours)
- Pressure pain detection threshold(0.5-10 hours)
- Pregabalin half life(0.5-10 hours)
- Electrical pain post-cold pressor pain detection threshold(0.5-10 hours)
- Conditioned pain modulation response pain detection threshold(0.5-10 hours)
- Maximum Observed Plasma Concentration (Cmax)(0.5-10)
- Cold pressor post test visual analogue scale(0.5-10 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0.5-10)
- Conditioned pain modulation pain tolerance threshold(0.5-10 hours)
- Pressure pain post test visual analogue scale(0.5-10 hours)
- PF-05089771 half life(0.5-10 hours)
- Electrical pain area under the visual analogue scale pain curve(0.5-10 hours)
- Electrical pain post cold pressor pain tolerance threshold(0.5-10 hours)
- Electrical pain post cold pressor area under the visual analogue scale curve(0.5-10 hours)
- Electrical pain post cold pressor post test visual analogue scale(0.5-10 hours)
- Cold pressor pain detection threshold(0.5-10 hours)
- Cold pressor area under the visual analogue scale curve(0.5-10 hours)
研究者
研究点 (1)
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