Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban (DRIVING)
This study is currently recruiting participants.
Verified March 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
CIC HEGP
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627665
First received: April 27, 2012
Last updated: June 21, 2012
Last verified: March 2011
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Purpose
The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: D->R->C+R Drug: D->R->C+D Drug: R->D->C+D Drug: R->D->C+R |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers |
Resource links provided by NLM:
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Dabigatran
Dabigatran etexilate
Rivaroxaban
Dabigatran etexilate mesylate
U.S. FDA Resources
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- AUC of plasma concentrations of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PKD of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: D->R->C+R
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
|
Drug: D->R->C+R
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
|
|
Active Comparator: D->R->C+D
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
|
Drug: D->R->C+D
one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
|
|
Active Comparator: R->D->C+D
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
|
Drug: R->D->C+D
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
|
|
Active Comparator: R->D->C+R
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban
|
Drug: R->D->C+R
RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
|
Detailed Description:
The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy participants
- Aged between 18-35 years inclusive
- Male
- Caucasian
- Body mass index (BMI) between 18 and 27 kg per m² inclusive.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627665
Contacts
| Contact: Anne Blanchard, MD | +33 1 56 09 29 13 | anne.blanchard@egp.aphp.fr |
Locations
| France | |
| CIC Hopital europeen george pompidou | Recruiting |
| Paris, France, 75015 | |
| Contact: anne blanchard 00 33 (1) 56 09 29 13 anne.blanchard@egp.aphp.fr | |
| Principal Investigator: Anne Blanchard, MD | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
CIC HEGP
Investigators
| Principal Investigator: | Anne Blanchard, MD | CIC HEGP |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01627665 History of Changes |
| Other Study ID Numbers: | P081208 |
| Study First Received: | April 27, 2012 |
| Last Updated: | June 21, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
dabigatran rivaroxaban PKC |
PKD p-glycoprotein polymorphism |
Additional relevant MeSH terms:
|
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013