Status:
COMPLETED
Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.
Lead Sponsor:
AstraZeneca
Conditions:
Bioavailability Heathy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.
Detailed Description
Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
Eligibility Criteria
Inclusion
- Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
- Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds \[lbs\]) and no more than 100 kg (220 lbs).
- Provision of signed and dated, written informed consent prior to any study specific procedures
Exclusion
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
- A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
- History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01887626
Start Date
July 1 2013
End Date
September 1 2013
Last Update
September 18 2013
Active Locations (1)
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1
Research Site
London, United Kingdom