NCT01951599已完成1 期
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
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
- 35
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)
研究概览
简要总结
To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.
详细描述
A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil.
- •In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.
排除标准
- •Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
- •Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
- •History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.
研究组 & 干预措施
AZD9291 20mg (oral capsule fasted)
Experimental
Volunteers will receive AZD9291 20mg administered by mouth, as a capsule, in the fasted state.
干预措施: AZD9291 (Drug)
AZD9291 20mg (oral solution fasted)
Experimental
Volunteers will receive AZD9291 20mg administered by mouth, as a solution, in the fasted state.
干预措施: AZD9291 (Drug)
AZD9291 20mg (oral tablet fasted)
Experimental
Volunteers will receive AZD9291 20mg administered by mouth, as a tablet, in the fasted state.
干预措施: AZD9291 (Drug)
AZD9291 20mg (oral fasted)
Experimental
Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fasted state.
干预措施: AZD9291 (Drug)
AZD9291 20mg (oral fed)
Experimental
Volunteers will receive AZD9291 20mg administered by mouth, as a capsule or tablet in the fed state.
干预措施: AZD9291 (Drug)
结局指标
主要结局
Pharmacokinetics of AZD9291 and its metabolites, by assessment of maximum plasma concentration (Cmax)
时间窗: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose
Curve taken during each of the 5 treatments
次要结局
- Pharmacokinetics of AZD9291 and its metabolites by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of time to Cmax (tmax)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal half life (t1/2,λz)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of Terminal rate constant (λz)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of lag time before observation of quantifiable analyte concentrations in plasma (tlag)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to time of last measurable concentration [AUC(0-t)](Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 and its metabolites, by assessment of area under the plasma concentration-time curve from zero to 72 hours [AUC(0-72)](Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 only, by assessment of apparent plasma clearance (CL/F).(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 only, apparent volume of distribution (Vz/F)(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
- Pharmacokinetics of AZD9291 parent to metabolite ratio (calculated for both Cmax and AUC).(Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post dose)
研究者
研究点 (1)
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