A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils Into the Circulation After Exercise and Subcutaneous
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 主要终点
- Circulating neutrophils during exercise challenge measured by average neutrophil values over time
研究概览
简要总结
Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and function (phagocytosis and oxidative burst) in the circulation, following a burst of strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)
详细描述
A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation after Exercise and Subcutaneous
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening
- •Only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal
- •Non-smokers or ex-smokers with no smoking history the last 12 months prior to Visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening
- •Body mass index (BMI) >18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg
排除标准
- •Subjects with a history of or active or latent tuberculosis (TB), or close contact with anybody with active TB
- •Subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin)
- •Subjects who are pyrexial with a body temperature of greater than 37.7 C at Visit 2, or as judged by the Investigator
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≥1.5 x upper limit of normal (ULN) at screening (Visit 2)
- •Peripheral blood neutrophils above or below the laboratory reference range at screening (Visit 2) hsCRP above the upper limit of the laboratory reference range at Visit 2
研究组 & 干预措施
1
AZD5069 100 mg capsules (50 mg BD) for 7 days
干预措施: 100 mg (50 mg x 2) AZD5069 (Drug)
2
Placebo twice daily for 7 days
干预措施: 100 mg Placebo (Drug)
结局指标
主要结局
Circulating neutrophils during exercise challenge measured by average neutrophil values over time
时间窗: Pre-dose, 10 min, 2h, 4 hours post exercise test
Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo
时间窗: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment.
Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)
时间窗: Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF
次要结局
- Adverse events(Screening to Day 63)
- Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing(Pre-dose on Days 1 - 4 On Day 3 with sampling pre-dose and at 1h, 2h, 3h, 5h, 8h, and 12 hours post dose)
- Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration(Pre-dose and 1, 2, 3, 5, 8, 12 hours post each dose on Days 1 - 4, Day 6 and Day 7)
- Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs, and physical examination findings will be presented(Screening to Day 63)