A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
研究概览
简要总结
- To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
- To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
- To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.
详细描述
Detailed Description:
Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.
On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nonsmokers
- •Male or female adults
排除标准
- •Current or history of significant medical illness
- •Illicit drug use
研究组 & 干预措施
Cohort 1
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
干预措施: Metformin (Drug)
Cohort 2
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
干预措施: PD 0332334 (Drug)
结局指标
主要结局
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
时间窗: Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
时间窗: Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
时间窗: Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
时间窗: Days 1 through 7
次要结局
- Clinical safety laboratories(Days 1 through 7)
- Incidence, duration and severity of adverse events when study medications administered alone and concurrently(Days 1 through 7)
- Discontinuation due to adverse events when study medications administered alone and concurrently(Days 1 through 7)
- 12-lead ECGs(Days 1 through 7)
- Vital signs(Days 1 through 7)