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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Esomeprazole/ASA; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210339

D961FC00010

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Esomeprazole/ASA

Drug: Clopidogrel

2

Experimental group

Description:

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

Treatment:

Drug: Esomeprazole/ASA

Drug: Clopidogrel