Study to Evaluate the Interaction Between Aspirin and Nexium

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01199328

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Aspirin Drug: Esomeprazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Aspirin 81 mg	Drug: Aspirin 81mg Tablet oral, once daily
Active Comparator: 2 Esomeprazole 20mg/aspirin 81mg	Drug: Aspirin 81mg Tablet oral, once daily Drug: Esomeprazole 20 mg Tablet oral, once daily Other Names: Nexium

Arm

Intervention/Treatment

Active Comparator: 1

Aspirin 81 mg

Drug: Aspirin

81mg Tablet oral, once daily

Active Comparator: 2

Esomeprazole 20mg/aspirin 81mg

Drug: Aspirin

81mg Tablet oral, once daily

Drug: Esomeprazole

20 mg Tablet oral, once daily

Other Names:

Nexium

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Springfield	Missouri	United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Dennis N Morrison, MD, Bio-Kinetic Clinical Applications
Study Director: Tore Lind, AstraZeneca
Study Chair: Lynne Durborow, AstraZeneca