An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients With Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 When Administered Intravenously, Orally, Inhaled Via SPIRA Nebuliser or Inhaled Via I-neb® AAD Systems
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
研究概览
简要总结
A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
- •Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- •Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
- •Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
- •Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath
排除标准
- •History of any clinically significant disease or disorder
- •Any clinically relevant abnormal findings
- •Current smokers
- •Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
- •Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
研究组 & 干预措施
1
AZD5423 iv
干预措施: AZD5423 (Drug)
2
AZD5423 inhalation, Spira
干预措施: AZD5423 (Drug)
3
AZD5423 inhalation I-neb
干预措施: AZD5423 (Drug)
4
AZD5423 oral
干预措施: AZD5423 (Drug)
结局指标
主要结局
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
时间窗: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
时间窗: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
时间窗: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
时间窗: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
次要结局
- To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax(Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period)
- To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.(From screening to follow-up)