Study to Evaluate the Interaction Between Aspirin and Nexium

Study Overview
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Brief Summary
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The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.

Official Title
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A Phase I, Open, Two-way Crossover, Drug-drug Interaction Study Evaluating the Effect of Esomeprazole on the Pharmacodynamics of Acetylsalicylic Acid After 5 Days of Treatment

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Aspirin
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision informed consent prior to any study specific procedures. Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture. Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control: Continuously practice abstinence during screening and throughout the duration of the study Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives. Have a body mass index (BMI) between 19 and 30 kg/m2 No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam. Exclusion Criteria: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Previous enrolment or randomisation in the present study. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. Any clinically significant illness within 4 weeks of the first administration of investigational product.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Aspirin 81 mg | Drug: Aspirin<br>* 81mg Tablet oral, once daily<br>|
| Active Comparator: 2<br>Esomeprazole 20mg/aspirin 81mg | Drug: Aspirin<br>* 81mg Tablet oral, once daily<br>Drug: Esomeprazole<br>* 20 mg Tablet oral, once daily<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers |  | Ongoing throughout the study from consent through withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline |  | Ongoing throughout the study from consent through withdrawal | 
| Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin |  | Ongoing throughout the study from consent through withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, Nexium, peptic ulcers, pharmacodynamic (PD), Esomoeprazole