NCT01147432已完成1 期
A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control
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
- 12
- 试验地点
- 1
- 主要终点
- Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
研究概览
简要总结
Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.
详细描述
Proof of mechanism in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 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 50 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.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- •Skintype I-III with a distance from base of scaphoid to antecubital fossa >26cm on their forearms.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
- •Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.
- •12-lead ECG demonstrating QTcF >450 msec at screening.
- •Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.
研究组 & 干预措施
PF-04427429
Experimental
干预措施: PF-04427429 (Drug)
PF-04427429
Experimental
干预措施: Capsaicin challenge (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Capsaicin challenge (Other)
EMLA
Active Comparator
干预措施: EMLA positive control (Other)
结局指标
主要结局
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
时间窗: 7 weeks post first dose
次要结局
- Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety(12 weeks post final dose)
- Plasma concentrations of free PF-04427429(6 weekly following week 15)
- Plasma concentrations of free and total CGRP(6 weekly following week 15)
- Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.(7 weeks post first dose)
研究者
研究点 (1)
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