Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin (IMAGINE)
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ClinicalTrials.gov Identifier: NCT01385683 |
Recruitment Status :
Completed
First Posted : June 30, 2011
Last Update Posted : March 22, 2012
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: Dabigatran then dabigatran and clarithromycin Drug: Clarithromycin and dabigatran then dabigatran | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
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Active Comparator: Arm A
Dabigatran then dabigatran and clarithromycin
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Drug: Dabigatran then dabigatran and clarithromycin
D4 : dabigatran 300 mg (4 tablets) one time. D8 to D10 : Clarithromycin 500mg (1 tablet) twice daily. D11 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets)
Other Names:
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Active Comparator: Arm B
Clarithromycin and dabigatran and dabigatran
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Drug: Clarithromycin and dabigatran then dabigatran
D1 to D3 : Clarithromycin 500mg (1 tablet) twice daily. D4 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets). D11 : dabigatran 300 mg (4 tablets) one time.
Other Names:
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- Determination of dabigatran and its metabolites in plasma by LC/MS-MS method [ Time Frame: At Day 4 and Day 11 ]Calculating the area under the curve (AUC) from plasma concentrations of dabigatran versus time by the trapezoidal method. Determination of maximum concentration (Cmax)
- Pharmacodynamic parameters [ Time Frame: At Day 4 and Day 11 ]Measures activated Partial Thromboplastin Time (aPTT)and measures ECarin Time (ECT),
- Genotyping [ Time Frame: At Day 1 ]Genotyping of MDR-1 (gene for P-GP): C3435T SNP of exon 26, SNP G2677T / A of exon 21 and C1236T SNP of exon 12

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- affiliated or beneficiary of a social security category
- having signed the inform consent form
- having signed the genetic consent form
- weight between 60 and 85 kg
- normal clinical exam
- normal biological exam
Exclusion Criteria:
- contra-indication to dabigatran
- contra-indication to clarithromycin
- previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease
- smoker
- peptic ulcer
- severe liver disease
- severe kidney failure
- previous surgery within one month

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385683
France | |
Service de Medecine et Therapeutique | |
Saint-Etienne, France, 42055 |
Principal Investigator: | Patrick MISMETTI, MD PhD | CHU de Saint-Etienne | |
Study Chair: | Xavier DELAVENNE, Pharmacist | CHU de Saint-Etienne |
Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT01385683 |
Other Study ID Numbers: |
1008073 2010-024047-33 ( EudraCT Number ) |
First Posted: | June 30, 2011 Key Record Dates |
Last Update Posted: | March 22, 2012 |
Last Verified: | March 2012 |
Healthy volunteer Pharmacokinetic pharmacodynamic Polymorphism, Genetic |
Clarithromycin Dabigatran Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Anticoagulants |