Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Healthy Clinical Trial

— BIPP  

Official title:

Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524210
• Other study ID #: 1208088
• Secondary ID: 2013-004932-3114
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2015
• Last updated: January 22, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Dabigatran
dabigatran etexilate 150 mg/day (1 day)
• Rabeprazole and Dabigatran
rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;
• Omeprazole and Dabigatran
omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran	Area under the curve (AUC) from plasma concentrations of dabigatran	baseline after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		0.25 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		0.5 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		1 hour after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		1.5 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		2 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		3 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		6 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		8 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		12 hours after each dose of dabigatran etexilate.	No
Primary	Area under the curve (AUC) from plasma concentrations of dabigatran		24 hours after each dose of dabigatran etexilate.	No