An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
研究概览
简要总结
Study to investigate relative bioavailability of up to five different formulations of AZD5069
详细描述
An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
- •Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
- •Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.
- •Healthy volunteers with neutrophil counts within the laboratory range at screening.
排除标准
- •A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
- •Healthy volunteers who have previously received AZD
- •Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
- •Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -
研究组 & 干预措施
Treatment A
Phase IIb formulation
干预措施: Phase IIb formulation (Drug)
Treatment B
Putative phase III formulation
干预措施: Putative phase III formulation (Drug)
Treatment C
Slow dissolution variant 1
干预措施: Slow dissolution variant 1 (Drug)
Treatment D
Slow dissolution variant 2
干预措施: Slow dissolution variant 2 (Drug)
Treatment E
Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069
干预措施: Test treatment E (Drug)
结局指标
主要结局
Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
时间窗: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)
时间窗: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)
时间窗: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)
时间窗: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
次要结局
- Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)(Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose)
- Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)(Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose)
- Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)(Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose)