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Completed

NCT Number: NCT01210339

An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.

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Key information

Conditions

Healthy Volunteers Cardiovascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
  • Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
  • Have a body mass index between 19 and 30 kg/m2 inclusive
  • No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion criteria

  • Any clinically significant abnormalities in laboratory screening results as judged by investigator
  • Platelet count <150 x 10^9/L on Day -1 or any other conditions that would increase the risk of bleeding
  • Previous bone marrow transplant
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG

Treatment and study plan

clopidogrel

Drug

Clopidogrel

Esomeprazole/ASA

Drug

20 mg/81 mg once daily for five days (Day 5-9)

Other names: Axanum

Primary outcomes

  1. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline

    Time frame: Pharmacodynamic sampling will be done before treatment period 1.

  2. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline

    Time frame: Pharmacodynamic sampling will be done after treatment period 1

  3. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline

    Time frame: Pharmacodynamic sampling will be done before treatment period 2.

  4. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline

    Time frame: Pharmacodynamic sampling will be done after treatment period 2.

Secondary outcomes

  1. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing Area Under Curve (AUC) and Cmax.after 9 days of clopidogrel treatment

    Time frame: Pharmacokinetic sampling will be done at the end of treatment period 1 and 2 (Day 9).

  2. The safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid

    Time frame: Safety will be monitored continuously. Adverse events will be collected from the first administration of Investigational Product (IP) throughout the study until the follow-up visit (on average) 7-10 days after last dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2010
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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