NCT00692510已完成1 期
A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity
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
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Provision of signed written informed consent
- •Clinically normal physical findings and laboratory values
排除标准
- •Clinically significant illness or clinically relevant trauma within three weeks before the first dose
- •History of clinically significant disease
- •Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
研究组 & 干预措施
1
Experimental
AZD3480 + cocktail
干预措施: AZD3480 (Drug)
1
Experimental
AZD3480 + cocktail
干预措施: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) (Drug)
2
Placebo Comparator
Placebo + cocktail
干预措施: Placebo (Drug)
2
Placebo Comparator
Placebo + cocktail
干预措施: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during the treatment periods
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
研究点 (1)
Loading locations...
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