NCT01210339 - An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

58

Conditions

Healthy Volunteers

Interventions

ClopidogrelDRUG

Clopidogrel

Esomeprazole/ASADRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

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.

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

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.

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

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).

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.