A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Open-label, crossover study recruiting 46 healthy male volunteers comparing the absorption of APO-dabigatran 150 mg per oral (PO) in the absence or presence of a proton pump inhibitor. Participants will serve as their own control when comparing dabigatran exposure in the absence or presence of the proton pump inhibitor, Rabeprazole 20 mg.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Health Research Institute
• Collaborator: Hamilton Health Sciences Corporation
• Treatments: Dabigatran; Rabeprazole

Criteria

Inclusion Criteria:

1. 20 to 40 years old

2. Body mass index 18-30 kg/m2

3. Male. Those able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information sheet.

Exclusion Criteria:

1. Any documented history of heart, lung, liver, kidney, gastrointestinal, genitourinary, musculoskeletal or endocrine disorders or other systemic illness not specifically listed.

2. Regular use of any medications or herbal supplements/remedies (e.g. St. John's wort).

3. Laboratory values outside of reference range that may compromise safety or validity of the trial.

4. Smoking or alcohol consumption such that the investigators feel that they will not be able to comply with the trial protocol.

5. Measures at screening outside of the reference ranges for systolic and diastolic blood pressure (>140/90) and pulse rate (>90/min).

6. Patients who are not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (includes any condition that, in the investigator's opinion, makes the patient an unreliable trial participant).

7. Previous enrollment in this trial.

8. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)