PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
2011年10月5日 更新者：Pfizer
A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions
This Phase 1 study is the first clinical trial in Japanese subjects.
This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.
研究概览
研究类型
介入性
注册 (实际的)
27
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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California
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Glendale、California、美国、91206
- 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 male and/or female subjects of non childbearing potential 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 >45 kg (99 lbs).
- Japanese subjects who have four Japanese grandparents born in Japan.
Exclusion Criteria:
- Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
- Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
- Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：单剂量
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口服单剂量作为匹配安慰剂
Oral single 5 mg dose as one 5 mg tablet
Oral single 10 mg dose as one 10 mg tablet
Oral single 30 mg dose as three 10 mg tablets
Oral multiple 20 mg doses as two 10 mg tablets for 12 days
Oral multiple doses as matching placebo for 12 days
|
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实验性的：多剂量
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口服单剂量作为匹配安慰剂
Oral single 5 mg dose as one 5 mg tablet
Oral single 10 mg dose as one 10 mg tablet
Oral single 30 mg dose as three 10 mg tablets
Oral multiple 20 mg doses as two 10 mg tablets for 12 days
Oral multiple doses as matching placebo for 12 days
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Plasma pharmacokinetic parameters for PF-00251802 : Cmax
大体时间：Day 1 to Day 4 in each period of Cohort A
|
Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for PF-00251802 : Tmax
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
|
|
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2
大体时间：Day 1 to Day 4 in each period of Cohort A
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Day 1 to Day 4 in each period of Cohort A
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|
Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for PF-00251802: Ctrough
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
|
Day 1 to Day 15 in Cohort B
|
|
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
|
Day 1 to Day 15 in Cohort B
|
|
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12
大体时间：Day 1 to Day 15 in Cohort B
|
Day 1 to Day 15 in Cohort B
|
|
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12
大体时间：Day 1 to Day 15 in Cohort B
|
Day 1 to Day 15 in Cohort B
|
|
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
大体时间：Day 1 to Day 15 in Cohort B
|
Day 1 to Day 15 in Cohort B
|
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Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough
大体时间：Day 1 to Day 15 in Cohort B
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Day 1 to Day 15 in Cohort B
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX).
大体时间：Day 0 to Day 15 in Cohort B
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Day 0 to Day 15 in Cohort B
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Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.
大体时间：Day 0 to Day 15 in Cohort B
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Day 0 to Day 15 in Cohort B
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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5月1日
初级完成 (实际的)
2011年8月1日
研究完成 (实际的)
2011年8月1日
研究注册日期
首次提交
2011年5月17日
首先提交符合 QC 标准的
2011年5月26日
首次发布 (估计)
2011年5月30日
研究记录更新
最后更新发布 (估计)
2011年10月7日
上次提交的符合 QC 标准的更新
2011年10月5日
最后验证
2011年10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.