A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
研究概览
简要总结
The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 or female (of non-child bearing potential) subjects between 18 and 55 years of age.
- •Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.
排除标准
- •Evidence or history of any clinically significant disease.
- •Treatment with an investigational drug within 30 days of study start
- •Use of prescription and non-prescription medicines within 7 days of study start
研究组 & 干预措施
Placebo
干预措施: PF-04634817 Placebo (Drug)
Cohort 1, 1mg
干预措施: PF-04634817 (Drug)
Cohort 1, 3mg
干预措施: PF-04634817 (Drug)
Cohort 1, 10mg
干预措施: PF-04634817 (Drug)
Cohort 2, 30mg
干预措施: PF-04634817 (Drug)
Cohort 2, 100mg
干预措施: PF-04634817 (Drug)
Cohort 2, 300mg
干预措施: PF-04634817 (Drug)
Cohort 3, 600mg
干预措施: PF-04634817 (Drug)
Cohort 3, 900mg
干预措施: PF-04634817 (Drug)
Cohort 3, up to 900mg (fed)
干预措施: PF-04634817 (Drug)
Cohort 3, placebo (fed)
干预措施: PF-04634817 Placebo (Drug)
结局指标
主要结局
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
时间窗: 0-3 days
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2
时间窗: 0-4 days
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr
时间窗: 0-2 days
p-ERK inhibition in human monocytes
时间窗: 0-3 days
Change in circulating monocytes
时间窗: 0-3 days
次要结局
- Change from baseline in plasma MCP-1(0-3 days)
- MIP 1B stimulated CCR5 receptor internalization(0-3 days)
- MCP-1 stimulated CCR5 receptor internalization(0-3 days)