NCT01627665

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2 healthy-volunteers

Timeline
Completed

Started Oct 2011

Typical duration for phase_2 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

March 1, 2011

Enrollment Period

2.7 years

First QC Date

April 27, 2012

Last Update Submit

October 8, 2014

Conditions

Healthy Volunteers

Keywords

dabigatranrivaroxabanPKCPKDp-glycoproteinpolymorphism

Outcome Measures

Primary Outcomes (1)

  • AUC of plasma concentrations of the drugs

    over 24h after single oral dose

Secondary Outcomes (1)

  • PKD of the drugs

    over 24h after single oral dose

Study Arms (4)

D->R->C+R

ACTIVE COMPARATOR

sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban

Drug: D->R->C+R

D->R->C+D

ACTIVE COMPARATOR

sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran

Drug: D->R->C+D

R->D->C+D

ACTIVE COMPARATOR

sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran

Drug: R->D->C+D

R->D->C+R

ACTIVE COMPARATOR

sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban

Drug: R->D->C+R

Interventions

D->R->C+RDRUG

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

D->R->C+R
D->R->C+DDRUG

one oral dose DABIGATRAN 300 mg -\> RIVAROXABAN 40 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

D->R->C+D
R->D->C+DDRUG

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg

R->D->C+D
R->D->C+RDRUG

RIVAROXABAN 40 mg -\> one oral dose DABIGATRAN 300 mg -\> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg

R->D->C+R

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants
  • Aged between 18-35 years inclusive
  • Male
  • Caucasian
  • Body mass index (BMI) between 18 and 27 kg per m² inclusive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Hopital europeen george pompidou

Paris, Paris, 75015, France

Location

Related Publications (2)

  • Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.

    PMID: 33369212DERIVED

  • Marques P, Courand PY, Gouin-Thibault I, Zhygalina V, Bergerot D, Salem JE, Funck-Brentano C, Loriot MA, Azizi M, Blanchard A. P-glycoprotein influences urinary excretion of aldosterone in healthy individuals. J Hypertens. 2019 Nov;37(11):2225-2231. doi: 10.1097/HJH.0000000000002150.

    PMID: 31157746DERIVED

Study Officials

  • Anne Blanchard, MD

    CIC HEGP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2012

First Posted

June 26, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 9, 2014

Record last verified: 2011-03

Locations

FR(1)