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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Clopidogrel; Drug: Esomeprazole/ASA

• Registration Number: NCT01210339
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Study Start: 2010-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Clopidogrel	Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days)
1	Esomeprazole/ASA	Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days)
2	Esomeprazole/ASA	Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days)
1	Clopidogrel	Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days)

Primary Outcome Measures

Name	Time	Method
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 after treatment period 2.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden