WILL lOWer dose aspirin Therapy ReducE the response to Endotoxin? – (WILLOW TREE)

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004285-34-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified