NCT03762928已完成1 期
A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ IN HEALTHY PARTICIPANTS
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
- single dose Area under the curve at last quantifiable infinity time of midazolam
研究概览
简要总结
The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.
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
- None
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
- •Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
- •Any condition possibly affecting drug absorption
- •Known immunodeficiency.
- •Infection with hepatitis B or hepatitis C viruses
- •acute or chronic infections or infection history judged to be clinically significant by the investigator
- •History of any lymphoproliferative disorder
- •known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.
研究组 & 干预措施
PF-06651600/midazolam/efavirenz
Experimental
干预措施: PF-06651600 (Drug)
midazolam/efavirenz
Experimental
干预措施: midazolam (Drug)
midazolam/efavirenz
Experimental
干预措施: efavirenz (Drug)
PF-06651600/midazolam/efavirenz
Experimental
干预措施: midazolam (Drug)
PF-06651600/midazolam/efavirenz
Experimental
干预措施: efavirenz (Drug)
结局指标
主要结局
single dose Area under the curve at last quantifiable infinity time of midazolam
时间窗: Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz
时间窗: hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose
次要结局
- number of subjects with significant change from baseline in vital signs(hour 0 on study days 1, 4, 10 and 13 post-dose)
- number of subjects with significant change from baseline in laboratory safety tests results(study days -1, 4, 13 post-dose)
- number of subjects with treatment emergent adverse events (TEAE)(Baseline up to 35 days post dose)
研究者
研究点 (1)
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