A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers

Pfizer1 个研究点分布在 1 个国家目标入组 63 人开始时间: 2010年11月最近更新: 2011年10月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Pfizer
入组人数: 63
试验地点: 1
主要终点: Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests.
•In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
•Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 50 kg (110 lbs).

排除标准

•Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
•Evidence or history of any chronic ongoing or current pulmonary disease.
•History of smoking in the past 5 years or history or evidence of habitual use of other (non-smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day
•Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
•Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.