NCT01812265已完成1 期
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Crossover Study To Investigate The Effects Of Pf-06305591 On Cold Pain In Healthy Male Subjects
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
- 16
- 试验地点
- 1
- 主要终点
- Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval
研究概览
简要总结
This study will evaluate the pharmacological activity of PF-06305591 in healthy male volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.
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 and clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 35 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Subjects unable to tolerate pre-study Cpressor testing at screening.
- •Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to
- •Broken skin on hands or forearms
研究组 & 干预措施
PF-06305591 Dose 1
Experimental
干预措施: PF-06305591 (Drug)
PF-06305591 Dose 2
Experimental
干预措施: PF-06305591 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval
时间窗: 24h
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline in a 2 minute assessment.
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](24h)
- Maximum Observed Plasma Concentration (Cmax)(24h)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male SubjectsPainNCT00747058Pfizer28
已完成
1 期
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult SubjectsHealthy VolunteersNCT00783484Pfizer37
已完成
1 期
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)HealthyNCT01844804Pfizer146
已完成
1 期
Safety and Tolerability Study of Multiple Doses of PF-06305591HealthyNCT01776619Pfizer43
已完成
1 期
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562HealthyNCT01914796Pfizer39