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A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

2013年3月12日 更新者:Pfizer

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

研究概览

研究类型

介入性

注册 (实际的)

42

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

      • Bruxelles、比利时、B-1070
        • Pfizer Investigational Site

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 between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Women must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • 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. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

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: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
实验性的:队列 1
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
实验性的:队列 2
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
实验性的:队列 3
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
实验性的:队列 4
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
实验性的:队列 5
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to 24 hour [AUC24]
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Apparent Oral Clearance (CL/F)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Apparent Volume of Distribution (Vz/F)
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
大体时间:0 to 24 hours post-dose
0 to 24 hours post-dose
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
大体时间:0 to 24 hours post-dose
0 to 24 hours post-dose
Renal Clearance (CLr)
大体时间:0 to 24 hours post-dose
0 to 24 hours post-dose
Oral temperature
大体时间:0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose

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

2012年6月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2012年5月30日

首先提交符合 QC 标准的

2012年6月20日

首次发布 (估计)

2012年6月25日

研究记录更新

最后更新发布 (估计)

2013年3月13日

上次提交的符合 QC 标准的更新

2013年3月12日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

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