The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
2016年5月6日 更新者：Pfizer
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers
The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.
研究概览
研究类型
介入性
注册 (实际的)
37
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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Michigan
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Kalamazoo、Michigan、美国、49007
- Jasper Clinic, Inc.
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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 or females willing to be confined and comply with scheduled visits
- Women are to be surgically sterile.
Exclusion Criteria:
- History of febrile illness within 5 days prior to the first dose
- Positive urine drug screen
- Treatment with an investigational product within 30 days prior to the first dose of study medication
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
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
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Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
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其他：Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
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Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
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其他：Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
其他：Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
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其他：Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
其他：Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
其他：Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
大体时间：8 days
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The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
大体时间：8 days
|
Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
大体时间：14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
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Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
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14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
大体时间：8 days
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Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
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8 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
大体时间：8 days
|
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
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8 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1)
大体时间：8 days
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Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
大体时间：8 days
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Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
大体时间：Day 6
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On Day 6 of each period, subjects will undergo an oral glucose tolerance test.
After ingesting 75 g of a glucose solution within 5 minutes of receiving their daily dose of prednisone, blood samples for glucose were obtained at 0.5, 1 and 2 hours.
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Day 6
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
大体时间：8 days
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Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
大体时间：7 days
|
Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
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7 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
大体时间：8 days
|
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
大体时间：7 days
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Change from baseline after 7 days of treatment in each treatment period.
The POMS is a copyrighted questionnaire that measures 6 dimensions of mood.
The subject will assess how 65 descriptors apply to him/her on a 5-point scale of 0 (not at all) to 4 (extremely).
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7 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
大体时间：7 days
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Change from baseline in sleep after 7 days of treatment will be assessed in each treatment period.
The patient-reported questionnaire consists of 12 items that assesses the key constructs of sleep.
Scores can range from 12-71 with higher number indicating more problems with sleep.
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7 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
大体时间：28 days after last dose of study medication in Period 3
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Subjects were monitored throughout the study and queried for adverse events
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28 days after last dose of study medication in Period 3
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
大体时间：8 days
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Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
大体时间：8 days
|
A post-void weight will be collected on the morning of Day 1 and Day 8 to assess change from baseline during each treatment period.
|
8 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
大体时间：8 days
|
Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
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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
2005年10月1日
初级完成 (实际的)
2006年3月1日
研究完成 (实际的)
2006年3月1日
研究注册日期
首次提交
2016年4月21日
首先提交符合 QC 标准的
2016年5月6日
首次发布 (估计)
2016年5月10日
研究记录更新
最后更新发布 (估计)
2016年5月10日
上次提交的符合 QC 标准的更新
2016年5月6日
最后验证
2016年5月1日
更多信息
与本研究相关的术语
其他研究编号
- A9001309
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.