NCT01734772

Brief Summary

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2012

Typical duration for phase_1 healthy

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

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

November 15, 2012

Results QC Date

April 2, 2014

Last Update Submit

April 2, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

    Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).

    47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

  • Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)

    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).

    47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Study Arms (3)

Reference (Part 1/A, Part 2/C)

EXPERIMENTAL

multiple doses of dabigatran (alone)

Drug: dabigatran etexilate

Test 1 (Part 1/Treatment B)

EXPERIMENTAL

concomitant administration of dabigatran and ticagrelor

Drug: dabigatran etexilateDrug: ticagrelor

Test 2 (Part 2/Treatment D)

EXPERIMENTAL

staggered administration of ticagrelor and dabigatran

Drug: ticagrelorDrug: dabigatran etexilate

Interventions

dabigatran etexilateDRUG

multiple doses of dabigatran

Test 1 (Part 1/Treatment B)
ticagrelorDRUG

loading dose of ticagrelor

Test 1 (Part 1/Treatment B)

Eligibility Criteria

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

You may qualify if:

  • \. Healthy male subjects.

You may not qualify if:

  • \. Any relevant deviation from healthy conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1160.142.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

DabigatranTicagrelor

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAdenosinePurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 5, 2014

Results First Posted

May 5, 2014

Record last verified: 2014-04

Locations

DE(1)