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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
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 male or females willing to be confined and comply with scheduled visits
- •Women are to be surgically sterile.
排除标准
- •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
研究组 & 干预措施
Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
干预措施: Prednisone (Drug)
Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
干预措施: Placebo (Drug)
Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
干预措施: Prednisone (Drug)
Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
干预措施: Prednisone (Drug)
Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
干预措施: Prednisone (Drug)
Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
干预措施: Prednisone (Drug)
Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
干预措施: Placebo (Drug)
Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
干预措施: Prednisone (Drug)
Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
干预措施: Prednisone (Drug)
Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
时间窗: 8 days
Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
时间窗: 8 days
The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
时间窗: 8 days
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
时间窗: 8 days
Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
时间窗: 8 days
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
时间窗: 8 days
Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
时间窗: Day 6
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.
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
时间窗: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
时间窗: 8 days
Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
时间窗: 7 days
Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
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)
时间窗: 8 days
Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
次要结局
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events(28 days after last dose of study medication in Period 3)
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure(8 days)
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)(7 days)
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate(8 days)
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight(8 days)
- Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State(7 days)