Clinical trial NCT02524210: Effect of Inhibitors of the Proton Pump on Intestinal Transporters
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: baseline after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 0.25 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 0.5 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 1 hour after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 1.5 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 2 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 3 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 6 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 8 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 12 hours after each dose of dabigatran etexilate.
measure: Area under the curve (AUC) from plasma concentrations of dabigatran
timeFrame: 24 hours after each dose of dabigatran etexilate.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Laurent BERTOLETTI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: