A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.
研究概览
简要总结
CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 and female subjects between the ages of 18 and 55 years.
- •Body Mass Index (BMI) of 27 to 40 kg/m
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
排除标准
- •Non-prescribed use of drugs of abuse/ recreational drugs;
- •Recent treatment with experimental drugs or herbal experiments;
- •EKG and blood pressure parameters falling outside of protocol-specified limits;
- •History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.
研究组 & 干预措施
CP-945,598 with Grapefruit Juice
CP-945,598 with Grapefruit Juice
干预措施: CP-945,598 (Drug)
CP-945,598 alone
CP-945,598 alone
干预措施: CP-945,598 (Drug)
结局指标
主要结局
Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.
时间窗: 21 days
Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22
时间窗: 21 days
Adverse event monitoring throughout duration of the study
时间窗: 21 days
次要结局
- Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.(2 days)