An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Interleukin 1 beta
研究概览
简要总结
The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
- •Signed informed consent
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months) gastrointestinal disease including peptic ulcer
- •Other protocol inclusion/exclusion criteria may apply
研究组 & 干预措施
Arm A
Specified dose on specified days
干预措施: Prenisolone (Drug)
Arm B
Specified dose on specified days
干预措施: Placebo (Drug)
结局指标
主要结局
Interleukin 1 beta
时间窗: Up to 32 days
As measured by flow cytometry
Cell Populations
时间窗: Up to 32 days
As measured by flow cytometry
Tumor necrosis factor-alpha
时间窗: Up to 32 days
As measured by flow cytometry
Receptor activator of nuclear factor-kB (RANK)
时间窗: Up to 32 days
As measured by flow cytometry
Receptor activator of nuclear factor-kB ligand (RANKL)
时间窗: Up to 32 days
As measured by flow cytometry
Osteoprotegrin (OPG)
时间窗: Up to 32 days
As measured by flow cytometry
Bone-specific alkaline phosphatase
时间窗: Up to 32 days
As measured by blood concentration
Calcium
时间窗: Up to 32 days
As measured by urine concentration
Oral glucose tolerance test
时间窗: Up to 32 days
Assessed by central labortatory
Cortisol
时间窗: Up to 32 days
As measured by the level of the hormone cortisol in the blood
Adrenocorticotropic hormone
时间窗: Up to 32 days
As measured by the level of the hormone in the blood
Osteocalcin
时间窗: Up to 32 days
As measured by blood concentration
Lipopolysaccharide Induced Cytokine Production
时间窗: Up to 32 days
As measured by blood concentration
N-terminal Pro-Collagen Peptide (PINP)
时间窗: Up to 32 days
As measured by blood concentration
Propetide type I C-term Pro-collagen Peptide (CICP)
时间窗: Up to 32 days
As measured by blood concentration
Urinary deoxypyridinoline
时间窗: Up to 32 days
As measured by urine concentration
C Telopeptide of Collagen Type II (CTX-II)
时间窗: Up to 32 days
As measured by urine concentration
Creatinine
时间窗: Up to 32 days
As measured by urine concentration
次要结局
未报告次要终点