Influence of Rabeprazole on the Magnitude of the Antiplatelet Action of Clopidogrel

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess, whether the administration of a proton pump inhibitor, Rabeprazole, has a negative effect on the activity of a concomitantly administered blood thinner drug. Proton pump inhibitors (PPI's) are prescribed for patients with gastric problems to reduce the gastric acid secretion. The blood thinner drug, Clopidogrel, administered in this trial is approved for the treatment of mild heart attacks; it works by preventing blood platelets from sticking together to form clots that would restrict blood flow. Previous trials have shown that the proton pump inhibitor omeprazole interacts with the blood thinning drug clopidogrel to reduce the active form of clopidogrel, thereby preventing the drug's blood thinning effect. In this trial, the effect of two different proton pump inhibitors, namely rabeprazole and omeprazole on the activity of the blood thinner drug clopidogrel will be assessed and compared to the effect of placebo on the activity of the blood thinner drug clopidogrel. This will be done in three sequential periods and each of the patients enrolled into this trial will be asked to participate in three different periods, during which clopidogrel with either rabeprazol, or omeprazol, or placebo will be administered daily.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Cilag S.A.S.
• Treatments: Clopidogrel; Omeprazole; Rabeprazole; Ticlopidine

Criteria

Inclusion Criteria:

• Healthy Volunteer in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results

• Body Mass Index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

• Non smoker or smokes <5 cigarettes /day, at least 6 months before first study drug

• ECG, blood pressure in normal range (blood pressure measured after the subject is sitting for 5 minutes, between 90 and 140 mm Hg systolic (inclusive) and no higher than 90 mmHg diastolic)

Exclusion Criteria:

• Personal or family history of coagulation or bleeding disorders

• Use of known inhibitors or inducers of CYP2C19 and CYP3A, including grape fruit juice intake

• Use of any prescription or non prescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) within 14 days prior to screening

• Known hypersensitivity to clopidogrel, rabeprazole, its excipients, omeprazole or substituted benzimidazoles

• Current clinically significant medical illness or history of clinically significant medical illness

• History of, or reason to believe a volunteer has a history of drug or alcohol abuse within the past 5 years