Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT03869268
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post-menopausal)\]
* Age between 18 and 65 years inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 28 kg/m2 inclusive, with a body weight between 60-100 kg
* 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
* Provision of informed consent before any trial-related activity
Exclusion Criteria:
* 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
* Any history of either significant multiple drug allergies or known allergy to the study drugs or any medicine chemically related to the study drugs
* A clinically-significant illness within 4 weeks of randomisation
* Any clinically-significant abnormal laboratory test results at screening in the opinion of the investigator
* A supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg
* A supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min
* Receipt of any prescribed or over-the-counter systemic or topical medication within 48 hours prior to the start of dosing
* 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, anthihistamine or any other drug that could affect inflammation, thrombosis or haemostasis in the opinion of the investigator.
* 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 weeks preceding the start of dosing. When reconfirming eligibility at the start of period 2, receipt of aspirin, ticagrelor or endotoxin during period 1 of this study will not be counted for this purpose.
* Any donation of blood or plasma in the month preceding the start of dosing.
* A history of alcohol or drug abuse
* Mental incapacity or language barriers that preclude adequate understanding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03869268
Study Brief:
Protocol Section:
NCT03869268