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

NCT00989300 | Completed Phase 1

• 3 other identifiers: CR016333RABGRD10082009-014756-29
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Drug-Drug interaction; Clopidogrel; Rabeprazol; Omeprazol; Pharmacodynamic Study

Outcome Measures

Primary Outcomes (1)

• The effect of rabeprazole and placebo on inhibition of platelet function after 7 daily standard 75 mg doses of clopidogrel in healthy male volunteers.

  Day 7 of period 1, 2 or 3

Secondary Outcomes (3)

• The difference in inhibiting the activity of clopidogrel after the administration of rabeprazole compared to placebo

  Measurement at day 7 of period 1, 2 or 3

• The difference in inhibiting the activity of clopidogrel after the administration of omeprazole compared to placebo

  measurement at day 7 of period 1, 2, or 3

• The difference in inhibiting the activity of clopidogrel after the administration of rabeprazole compared to omeprazole.

  measurement at day 7 of period 1, 2, or 3

Study Arms (2)

Treatment group

EXPERIMENTAL

patients received clopidogrel 75 mg with rabeprazole 20 mg, omeprazole 20 mg, or placebo in a crossover manner

Drug: Treatment A - rabeprazole; Drug: Treatment B - omeprazole

Placebo group

PLACEBO COMPARATOR

Other: Treatment C - placebo

Interventions

Treatment A - rabeprazole DRUG

20 mg rabeprazole sodium once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing

Treatment group

Treatment B - omeprazole DRUG

20 mg omeprazole once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing

Treatment group

Treatment C - placebo OTHER

placebo once daily for 7 days, in combination with 75 mg clopidogrel once daily for 7 days, oral dosing

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag S.A.S.: lead

Related Links

• Influence of rabeprazole on the magnitude of the antiplatelet action of clopidogrel. A prospective, placebo and active treatment-controlled, open-label, randomized 3-way cross over study in healthy subjects

Study Officials

• Janssen-Cilag S.A.S. Clinical Trial

  Janssen Cilag S.A.S.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 5, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 21, 2012

Record last verified: 2012-09