Status:
COMPLETED
Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.
Detailed Description
A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the ...
Eligibility Criteria
Inclusion
- Provision of signed and dated written informed consent prior to any study-specific procedures
- Healthy male subjects aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture
Exclusion
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- A history of hemophilia, von Willebrand's disease, lupus anti-coagulant, 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 hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage, or rectal bleeding within 1 year
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01504906
Start Date
January 1 2012
End Date
June 1 2012
Last Update
December 12 2012
Active Locations (1)
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1
Research site
Overland Park, Kansas, United States