A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Japanese Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis)
研究概览
简要总结
The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis). The secondary objectives of the study are to investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by assessment of the degree of accumulation, dose proportionality and time linearity in healthy Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single and multiple ascending doses of AZD3199 by assessment of potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and FEV1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years.
- •BMI 18 - 27, Weight 50 - 85 kg
- •Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
- •Clinical normal physical findings
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- •Use of any medication (including OTC), herbal preparations, vitamins or nutritional supplements within 2 weeks prior to Visit 2, except for occasional intake of paracetamol (maximum daily dose of 4 g)
研究组 & 干预措施
1
Dry powder for oral inhalation
干预措施: AZD3199 Turbuhaler® (Drug)
2
Dry powder for oral inhalation
干预措施: Placebo Turbuhaler® (Drug)
结局指标
主要结局
Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis)
时间窗: During the study
次要结局
- Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199.(During residential period)
- Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1).(During residential period)