Clinical trial NCT01199328: Study to Evaluate the Interaction Between Aspirin and Nexium
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Nexium
aspirin
peptic ulcers
pharmacodynamic (PD)
Esomoeprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Ongoing throughout the study from consent through withdrawal
Secondary outcomes:
measure: Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline
timeFrame: Ongoing throughout the study from consent through withdrawal
measure: Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin
timeFrame: Ongoing throughout the study from consent through withdrawal
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Research Site
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications
name: Dennis N Morrison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Tore Lind
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Lynne Durborow
role: STUDY_CHAIR
References:
citation: 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.