Study to Evaluate the Interaction Between Aspirin and Nexium

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Aspirin; Drug: Esomeprazole

• Registration Number: NCT01199328
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Esomeprazole	Esomeprazole 20mg/aspirin 81mg
1	Aspirin	Aspirin 81 mg
2	Aspirin	Esomeprazole 20mg/aspirin 81mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Springfield, Missouri, United States