Healthy Volunteers
Conditions
Keywords
phase 1, cross-over, drug-drug Interaction, esomeprazole, acetylsalicylic acid, clopidogrel, healthy volunteers, cardiovascular disease, patients with acid associated gastrointestinal symptoms
Brief summary
The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.
Interventions
DRUGClopidogrel
Clopidogrel
DRUGEsomeprazole/ASA
20 mg/81 mg once daily for five days (Day 5-9)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Pharmacodynamic sampling will be done before treatment period 1. |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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. |
Countries
Sweden
Outcome results
None listed