Status:
COMPLETED
The Antiplatelet and Immune Response Trial
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Platelets are the main type of blood cell involved in the formation of blood clots that cause heart attacks. The investigators give antiplatelet drugs (aspirin, for example) to reduce the risk of anot...
Eligibility Criteria
Inclusion
- 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
- Subjects are to be 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
- Subjects have given their informed consent before any trial-related activity
Exclusion
- In the opinion of the investigator, subjects with, or a history of, cancer, diabetes or clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric, or other major disorders
- Subjects with a history of significant multiple drug allergies or with a known allergy to the study drugs or a medicine chemically related to the trial product
- Subjects who have had a clinically significant illness within 4 weeks of dosing
- Subjects taking regular medicines including NSAIDs, antibiotics, aspirin or anticoagulant therapy
- Any clinically significant abnormal laboratory test results at screening
- Subjects who have a supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg
- Subjects who have a supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min
- Subjects who have received any prescribed systemic or topical medication within two weeks prior to the start of dosing. Limited use of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) prior to the initiation of the study will not necessarily require exclusion unless there is an ongoing requirement for these medications.
- Subjects who have received 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
- Subjects who have donated any blood or plasma in the month preceding the start of dosing
- Subjects who have a history of alcohol or drug abuse
- Subjects with mental incapacity or language barriers which preclude adequate understanding
- Subjects with a contraindication to ticagrelor (as listed in the SmPC - hypersensitivity to the active substance or any of its excipients, active pathological bleeding, history of intracranial hemorrhage, moderate to severe hepatic impairment and co-administration with strong CYP3A4 inhibitors)
- Subjects with a contraindication to clopidogrel (as listed in the SmPC - hypersensitivity to the active substance or any of its excipients, severe hepatic impairment, active pathological bleeding such as peptic ulcer or intracranial haemorrhage)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01846559
Start Date
April 1 2013
End Date
January 1 2014
Last Update
September 27 2021
Active Locations (1)
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1
Sheffield Clinical Research Facility
Sheffield, South Yorkshire, United Kingdom, S5 7AU