Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
2012年6月21日 更新者:Pfizer
Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects
Study of a drug drug interaction between Paroxetine and PF-00299804.
研究概览
研究类型
介入性
注册 (实际的)
14
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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New Haven、Connecticut、美国、06511
- Pfizer Investigational Site
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:DDI
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Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.
Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3).
Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10).
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
大体时间:8 weeks
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8 weeks
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次要结果测量
结果测量 |
大体时间 |
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Plasma CL/F of PF-00299804 in EM without paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma Tmax of PF-00299804 in EM without paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma t1/2 of PF-00299804 in EM without paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma MRT of PF-00299804 in EM without paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma CL/F of PF-00299804 in EM with paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma Tmax of PF-00299804 in EM with paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma t1/2 of PF-00299804 in EM with paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma MRT of PF-00299804 in EM with paroxetine.
大体时间:8 weeks
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8 weeks
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Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).
大体时间:8 weeks
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8 weeks
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Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).
大体时间:8 weeks
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8 weeks
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Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).
大体时间:8 weeks
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8 weeks
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Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
大体时间:8 weeks
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8 weeks
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Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
大体时间:8 weeks
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8 weeks
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Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
大体时间:8 weeks
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8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2011年6月1日
研究完成 (实际的)
2011年6月1日
研究注册日期
首次提交
2011年2月17日
首先提交符合 QC 标准的
2011年3月16日
首次发布 (估计)
2011年3月18日
研究记录更新
最后更新发布 (估计)
2012年6月22日
上次提交的符合 QC 标准的更新
2012年6月21日
最后验证
2012年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Period 1的临床试验
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Fudan UniversityThe First Affiliated Hospital of Anhui Medical University; Guangdong Provincial Hospital of... 和其他合作者撤销