EUCTR2018-004285-34-GB进行中（未招募）1 期
The impact of aspirin dose modification on the innate immune response - WILL lOWer dose aspirin Therapy ReducE the response to Endotoxin? – (WILLOW TREE) - WILLOW TREE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •To participate in this trial, subjects must meet all of the following criteria:
- •1.Healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post-menopausal)
- •2.Age between 18 and 65 years inclusive
- •3.Non-smokers
- •4.Body mass index (BMI) between 18 and 28 kg/m2 inclusive, with a body weight between 60-100 kg
- •5.In good health as determined by a medical history, physical examination, vital signs and clinical laboratory test results, including renal and liver function, and full blood count
- •6.Provision of informed consent before any trial-related activity
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects meeting any of the following criteria will be excluded from participation in the study:
- •1. Any history of cancer, diabetes or, in the opinion of the investigator, clinically-significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric or other major disorders
- •2. Any history of either significant multiple drug allergies or known allergy to the study drugs or any medicine chemically related to the study drugs
- •3. A clinically-significant illness within 4 weeks of randomisation
- •4. Any clinically-significant abnormal laboratory test results at screening, in the opinion of the investigator
- •5. A supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg
- •6. A supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min
- •7. Receipt of any prescribed or over-the-counter systemic or topical medication within 48 hours prior to the start of dosing
- •8. Planned or expected requirement, during the next 3 months (at randomisation, or 3 weeks at the start of period 2), for any systemic or topical prescribed drug, or for systemic or topical over-the-counter NSAID, corticosteroid, antihistamine or any other drug that could affect inflammation, thrombosis or haemostasis in the opinion of the investigator.
- •9. Receipt of an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three months preceding the start of dosing. When reconfirming eligibility at the start of period 2, receipt of aspirin (aspirin lysine), ticagrelor or endotoxin during period 1 of this study will not be counted for this purpose.
- •10. Any donation of blood or plasma in the month preceding the start of dosing.
- •11. A history of alcohol or drug abuse
- •12. Mental incapacity or language barriers that preclude adequate understanding
- •13. Any other factor that, in the opinion of the investigator, would affect the
- •participant’s ability to safely and reliably complete the study, or would affect the scientific validity of the results obtained.
研究者
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