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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210339
• Other study ID #: D961FC00010
• Status: Completed
• Phase: Phase 1
• First received: September 27, 2010
• Last updated: October 6, 2011
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Clopidogrel
Clopidogrel
• Esomeprazole/ASA
20 mg/81 mg once daily for five days (Day 5-9)

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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 1	No
Primary	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 2.	No
Primary	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.	No
Secondary	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).	No
Secondary	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.	Yes