NCT01318031已完成1 期
Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy 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
- 14
- 试验地点
- 1
- 主要终点
- Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
研究概览
简要总结
Study of a drug drug interaction between Paroxetine and PF-00299804.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy males or females of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •An informed consent document signed and dated by the subject.
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Subjects must be extensive CYP2D6 metabolizers as determined by genotyping.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •History of depression or other potential for increased suicidality with paroxetine.
- •Family or personal medical history of prolonged QTc, congenital deafness or sudden death, or 12-lead ECG with QTc>450 msec.
- •A positive urine drug screen, use of tobacco or nicotine-containing products, or regular alcohol consumption exceeding 14 drinks/ week for females or 21 drinks/week for men within prior 6 months.
- •Pregnant or nursing females and females of childbearing potential including those with tubal ligation. Women of 45 to 55 years of age who are postmenopausal must have confirmatory FSH test results at screening.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
研究组 & 干预措施
DDI
Experimental
干预措施: Period 1 (Drug)
DDI
Experimental
干预措施: Period 2 (Drug)
结局指标
主要结局
Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
时间窗: 8 weeks
次要结局
- Plasma CL/F of PF-00299804 in EM without paroxetine.(8 weeks)
- Plasma Tmax of PF-00299804 in EM without paroxetine.(8 weeks)
- Plasma t1/2 of PF-00299804 in EM without paroxetine.(8 weeks)
- Plasma MRT of PF-00299804 in EM without paroxetine.(8 weeks)
- Plasma CL/F of PF-00299804 in EM with paroxetine.(8 weeks)
- Plasma Tmax of PF-00299804 in EM with paroxetine.(8 weeks)
- Plasma t1/2 of PF-00299804 in EM with paroxetine.(8 weeks)
- Plasma MRT of PF-00299804 in EM with paroxetine.(8 weeks)
- Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).(8 weeks)
- Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).(8 weeks)
- Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).(8 weeks)
- Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).(8 weeks)
- Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).(8 weeks)
- Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.(8 weeks)
研究者
研究点 (1)
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