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Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban (DRIVING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627665
First received: April 27, 2012
Last updated: October 8, 2014
Last verified: March 2011

April 27, 2012
October 8, 2014
October 2011
June 2014   (final data collection date for primary outcome measure)
AUC of plasma concentrations of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01627665 on ClinicalTrials.gov Archive Site
PKD of the drugs [ Time Frame: over 24h after single oral dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
  • Drug: D->R->C+R
    one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
  • Drug: D->R->C+D
    one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
  • Drug: R->D->C+D
    RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
  • Drug: R->D->C+R
    RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
  • Active Comparator: D->R->C+R
    sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
    Intervention: Drug: D->R->C+R
  • Active Comparator: D->R->C+D
    sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
    Intervention: Drug: D->R->C+D
  • Active Comparator: R->D->C+D
    sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
    Intervention: Drug: R->D->C+D
  • Active Comparator: R->D->C+R
    sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban
    Intervention: Drug: R->D->C+R
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy participants
  • Aged between 18-35 years inclusive
  • Male
  • Caucasian
  • Body mass index (BMI) between 18 and 27 kg per m² inclusive.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01627665
P081208
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Anne Blanchard, MD CIC HEGP
Assistance Publique - Hôpitaux de Paris
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP