Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran; Drug: Rabeprazole and Dabigatran; Drug: Omeprazole and Dabigatran

• Registration Number: NCT02524210
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases the risk of gastrointestinal bleeding compared to standard treatment (AVK) \[3\]. In these circumstances the risk / benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump (IPP).

Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-05
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• weight between 60 and 85 kg
• normal clinical exam
• normal biological exam

Exclusion Criteria

• hypersensitivity to dabigatran or any of its excipients
• hypersensitivity to omeprazole or rabeprazole or any of its excipients
• previous history of hemorrhagic disease
• insufficiency liver
• severe kidney failure
• peptic ulcer
• Any drug taken during the week before the start of the study
• smoker
• Consumption of grapefruit juice
• practice of violent sport

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm B	Omeprazole and Dabigatran	* Period "Rabeprazole + Dabigatran " * Washout period (at least 6 days) * Period " Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm C	Rabeprazole and Dabigatran	* Period " Rabeprazole + Dabigatran" * Period " Omeprazole + Dabigatran" * Period " Dabigatran"
Arm A	Omeprazole and Dabigatran	* Period " Dabigatran" * Washout period (at least 6 days) * Period " Rabeprazole + Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm C	Omeprazole and Dabigatran	* Period " Rabeprazole + Dabigatran" * Period " Omeprazole + Dabigatran" * Period " Dabigatran"
Arm A	Rabeprazole and Dabigatran	* Period " Dabigatran" * Washout period (at least 6 days) * Period " Rabeprazole + Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm B	Rabeprazole and Dabigatran	* Period "Rabeprazole + Dabigatran " * Washout period (at least 6 days) * Period " Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm A	Dabigatran	* Period " Dabigatran" * Washout period (at least 6 days) * Period " Rabeprazole + Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm B	Dabigatran	* Period "Rabeprazole + Dabigatran " * Washout period (at least 6 days) * Period " Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran"
Arm C	Dabigatran	* Period " Rabeprazole + Dabigatran" * Period " Omeprazole + Dabigatran" * Period " Dabigatran"

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) from plasma concentrations of dabigatran	24 hours after each dose of dabigatran etexilate.

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France