NCT01217918已完成1 期
APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult 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
- 30
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
研究概览
简要总结
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
排除标准
- •Subjects with clinically significant skin lesions
- •Subjects with known tuberculosis infection
研究组 & 干预措施
Cohotr 3
Experimental
PH-797804
干预措施: 10 mg (Drug)
Cohort 1
Experimental
PH-797804
干预措施: 1 mg (Drug)
Cohort 2
Experimental
PH-797804
干预措施: 5 mg (Drug)
结局指标
主要结局
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
时间窗: Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
时间窗: Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
时间窗: Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
时间窗: Days 1 and 10
次要结局
未报告次要终点
研究者
研究点 (1)
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