Study to Evaluate the Interaction Between Aspirin and Nexium

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199328
• Other study ID #: D961FC00011
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2010
• Last updated: November 18, 2010
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Aspirin
81mg Tablet oral, once daily
• Esomeprazole
20 mg Tablet oral, once daily

Locations

Country	Name	City	State
United States	Research Site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin		Ongoing throughout the study from consent through withdrawal	Yes