NCT01199900已完成1 期
An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
研究概览
简要总结
This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg
排除标准
- •Fasting glucose above the limits of the reference range for healthy individuals
- •"No treatment" Oral Glucose Tolerance Test (OGTT) indicative of impaired fasting glucose or impaired glucose tolerance
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
研究组 & 干预措施
(Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT
Experimental
干预措施: PF-04171327 (Drug)
(Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT
Experimental
干预措施: PF-04171327 (Drug)
(Part 1) 5 mg Prednisone
Active Comparator
5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
干预措施: Prednisone (Drug)
(Part 2) 3 mg PF-04171327
Experimental
干预措施: PF-04171327 (Drug)
(Part 2) 10 mg PF-04171327
Experimental
干预措施: PF-04171327 (Drug)
(Part 2) 5 mg Prednisone
Active Comparator
干预措施: Prednisone (Drug)
(Part 2) 20 mg Prednisone
Active Comparator
干预措施: Prednisone (Drug)
结局指标
主要结局
Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
时间窗: 4 hours
次要结局
- Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma c-peptide(3 days)
- Safety: adverse events, vital sign measurements, physical examination(3 days)
- Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)(3 days)
研究者
研究点 (1)
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