HealthyPhase 1BIPPNCT02524210
Effect of Inhibitors of the Proton Pump on Intestinal Transporters
A Phase 1 study testing Dabigatran, Rabeprazole and Dabigatran and Omeprazole and Dabigatran in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran, Rabeprazole and Dabigatran and Omeprazole and Dabigatran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- weight between 60 and 85 kg
- normal clinical exam
- normal biological exam
Who cannot join
- 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
Show all 10Show fewer
- Any drug taken during the week before the start of the study
- smoker
- Consumption of grapefruit juice
- practice of violent sport
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Dabigatran, Rabeprazole and Dabigatran, Omeprazole and Dabigatran
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
dabigatran etexilate 150 mg/day (1 day)
Rabeprazole and DabigatranDrug
rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;
Omeprazole and DabigatranDrug
omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | * Period " Dabigatran"
* Washout period (at least 6 days)
* Period " Rabeprazole + Dabigatran"
* Washout period (at least 6 days)
* Period " Omeprazole + Dabigatran" Receives: Drug: Dabigatran; Drug: Rabeprazole and Dabigatran; Drug: Omeprazole and Dabigatran |
| Arm B | Experimental | * Period "Rabeprazole + Dabigatran "
* Washout period (at least 6 days)
* Period " Dabigatran"
* Washout period (at least 6 days)
* Period " Omeprazole + Dabigatran" Receives: Drug: Dabigatran; Drug: Rabeprazole and Dabigatran; Drug: Omeprazole and Dabigatran |
| Arm C | Experimental | * Period " Rabeprazole + Dabigatran"
* Period " Omeprazole + Dabigatran"
* Period " Dabigatran" Receives: Drug: Dabigatran; Drug: Rabeprazole and Dabigatran; Drug: Omeprazole and Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) from plasma concentrations of dabigatran
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: baseline after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 0.25 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 0.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 1 hour after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 1.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 2 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 3 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 6 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 8 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 12 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Measured: 24 hours after each dose of dabigatran etexilate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BERTOLETTI, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524210
- Sponsor's protocol ID
- 1208088
- Other IDs
- 2013-004932-31, 140096A-21
- Acronym
- BIPP
- Status last verified
- Jan 2016
- First submitted
- 13 Aug 2015
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02524210
- Acronym / sponsor ID
- BIPP / 1208088
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Dabigatran, Drug: Rabeprazole and Dabigatran, Drug: Omeprazole and Dabigatran* Period " Dabigatran" * Washout period (at least 6 days) * Period " Rabeprazole + Dabigatran" * Washout period (at least 6 days) * Period " Omeprazole + Dabigatran" |
| Arm B | Experimental | Drug: Dabigatran, Drug: Rabeprazole and Dabigatran, Drug: 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 | Experimental | Drug: Dabigatran, Drug: Rabeprazole and Dabigatran, Drug: Omeprazole and Dabigatran* Period " Rabeprazole + Dabigatran" * Period " Omeprazole + Dabigatran" * Period " Dabigatran" |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- weight between 60 and 85 kg
- normal clinical exam
- normal biological exam
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatrandabigatran etexilate 150 mg/day (1 day) | Drug | Arm A, Arm B, Arm C |
| Rabeprazole and Dabigatranrabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg; | Drug | Arm A, Arm B, Arm C |
| Omeprazole and Dabigatranomeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate | Drug | Arm A, Arm B, Arm C |
Primary outcome
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
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 0.25 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 0.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 1 hour after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 1.5 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 2 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 3 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 6 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 8 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 12 hours after each dose of dabigatran etexilate.
Area under the curve (AUC) from plasma concentrations of dabigatran
Time frame: 24 hours after each dose of dabigatran etexilate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BERTOLETTI, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabigatran, Rabeprazole and Dabigatran and Omeprazole and Dabigatran in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) from plasma concentrations of dabigatran (time frame: baseline after each dose of dabigatran etexilate.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.