A 2-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Alanine Aminotransferase (ALT)
研究概览
简要总结
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate COPD
- •Smokers or ex-smokers
- •post-menopausal females
排除标准
- •Past history or current evidence of clinically significant heart disease
- •Lung disease other than COPD
- •Treatment with systemic steroids within 8 weeks of study visit 2
- •Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
研究组 & 干预措施
1
Active Treatment
干预措施: AZD9668 (Drug)
2
Placebo Treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Alanine Aminotransferase (ALT)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
ALT level greater than 3 times the upper limit of normal
Aspartate Aminotransferase (AST)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
AST level greater than 3 times the upper limit of normal
Creatine Kinase (CK)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Total Bilirubin
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Creatinine
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatinine level greater than the upper limit of normal
Haemoglobin (Hb)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Reticulocytes
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Leucocytes
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF interval greater than 450 ms
QTcF
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF change from baseline greater than 60 ms
FEV1 (Forced Expiratory Volume in the First Second)
时间窗: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
时间窗: Pre-dose on day -1 to day 15 (end of dosing)
AUC(0-12) following 14 days' dosing
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
时间窗: Pre-dose on day -1 to day 15 (end of dosing)
Cmax following 14 days' dosing
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
时间窗: Pre-dose on day -1 to day 15 (end of dosing)
tmax following 14 days' dosing
Terminal Half-life of Drug in Plasma (t1/2)
时间窗: Pre-dose on day -1 to day 15 (end of dosing)
t1/2 following 14 days' dosing
Renal Clearance of Drug From Plasma (CLR)
时间窗: Pre-dose on day -1 to day 15 (end of dosing)
CLR following 14 days' dosing
次要结局
- Sputum Absolute Neutrophil Count(Pre-dose day -1 to post-dose on day 14)
- Sputum Differential Neutrophil Count(Pre-dose day -1 to post-dose on day 14)
- AZD9668 Sputum Concentrations(Pre-dose day -1 to post-dose on day 14)
- Quantitative Sputum Bacteriology(Pre-dose day -1 to post-dose on day 15)