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临床试验/NCT01934569
NCT01934569已完成1 期

Evaluation Of The Effect Of PF-05089771 On The Metabolism Of Multiple Cytochrome P450 And OATP1B1 Transporter Substrates

Pfizer1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年9月最近更新:
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
17
试验地点
1
主要终点
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

研究概览

简要总结

This study will test the potential for PF-05089771 to interact with a cocktail of drugs

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Healthy male and/or female subjects between the ages of 18 and 55 years;
  • 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

  • Any condition possibly affecting drug absorption
  • History of regular alcohol consumption
  • Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic),
  • Consumption of coffee, cola or other caffeine containing drinks

研究组 & 干预措施

Active tratment

Experimental

Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771

干预措施: Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 (Drug)

结局指标

主要结局

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

时间窗: 24h

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

时间窗: 24h

Minimum Observed Plasma Trough Concentration (Cmin)

时间窗: 24h

Time to Reach Maximum Observed Plasma Concentration (Tmax)

时间窗: 24h

次要结局

  • Change from Baseline in Lipid Parameters(14 days)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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