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Completed

NCT Number: NCT02524210

Effect of Inhibitors of the Proton Pump on Intestinal Transporters

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dabigatran

Drug

dabigatran etexilate 150 mg/day (1 day)

Rabeprazole and Dabigatran

Drug

rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;

Omeprazole and Dabigatran

Drug

omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate

Primary outcomes

  1. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: baseline after each dose of dabigatran etexilate.

    Area under the curve (AUC) from plasma concentrations of dabigatran

  2. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 0.25 hours after each dose of dabigatran etexilate.

  3. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 0.5 hours after each dose of dabigatran etexilate.

  4. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 1 hour after each dose of dabigatran etexilate.

  5. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 1.5 hours after each dose of dabigatran etexilate.

  6. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 2 hours after each dose of dabigatran etexilate.

  7. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 3 hours after each dose of dabigatran etexilate.

  8. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 6 hours after each dose of dabigatran etexilate.

  9. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 8 hours after each dose of dabigatran etexilate.

  10. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 12 hours after each dose of dabigatran etexilate.

  11. Area under the curve (AUC) from plasma concentrations of dabigatran

    Time frame: 24 hours after each dose of dabigatran etexilate.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: BIPP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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