NCT01183715已完成1 期
A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers
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
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
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-05161704 in healthy volunteers.
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
- 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 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 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (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.
- •History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening or positive cotinine test at screening or Day 0 of period one
研究组 & 干预措施
Cohort 1
Experimental
Subjects in Cohort 1 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-05161704 will be administered in Period 4 in the fasted state.
干预措施: PF-05161704 or placebo (Drug)
Cohort 2
Experimental
Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3
干预措施: PF-05161704 or placebo (Drug)
结局指标
主要结局
Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
时间窗: 1 month
Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145
时间窗: 1 month
次要结局
- Preliminary pharmacodynamics of PF-05161704(1 month)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study Of PF-05175157 In Healthy VolunteersDiabetes Mellitus, Type 2NCT01274663Pfizer63
已完成
1 期
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic PatientsDiabetes Mellitus, Type 2NCT01396161Pfizer64
已完成
1 期
A Study of ACE-2494 in Healthy SubjectsHealthy VolunteersNCT03478319Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA48
已完成
1 期
A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT01044537Pfizer50
已完成
1 期
Multiple Dose Study of PF-04991532 in Patients With Type 2 DiabetesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2NCT01129258Pfizer110