Study to Evaluate the Interaction Between Aspirin and Nexium

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Aspirin; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dennis N Morrison, MD, Bio-Kinetic Clinical Applications; Study Director: Tore Lind, AstraZeneca

Publications and helpful links

General Publications

• Andersson T, Morrison D, Nagy P, Pisupati J, Schettler J, Warner TD. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):217-24. doi: 10.1007/BF03261830.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2010
• Last Update Submitted That Met QC Criteria: November 18, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: aspirin; Nexium; pharmacodynamic (PD); peptic ulcers; Esomoeprazole
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Aspirin; Esomeprazole
• Other Study ID Numbers: D961FC00011