Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01595854
First received: May 9, 2012
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: dabigatran etexilate
Drug: Ticagrelor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dabigatran Etexilate 220 mg - Part 1 A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
Ticagrelor 180 mg - Part 1 A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
Dabigatran Etexilate 220 mg - Part 2 A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
Ticagrelor 180 mg - Part 2 A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3

A randomised, two-period, cross-over trial, the two treatments administered were

  • A single dose of dabigatran etexilate 75 mg
  • Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.

Between treatment periods there was a washout period of at least 4 days.


Participant Flow:   Overall Study
    Dabigatran Etexilate 220 mg - Part 1     Ticagrelor 180 mg - Part 1     Dabigatran Etexilate 220 mg - Part 2     Ticagrelor 180 mg - Part 2     Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3  
STARTED     8     4     8     4     12  
COMPLETED     8     4     8     4     12  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dabigatran Etexilate 220 mg - Part 1 A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
Ticagrelor 180 mg - Part 1 A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
Dabigatran Etexilate 220 mg - Part 2 A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
Ticagrelor 180 mg - Part 2 A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3

A randomised two-period cross-over trial, the two treatments administered were

  • A single dose of dabigatran etexilate 75 mg
  • Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.

Between treatment periods there was a washout period of at least 4 days.

Total Total of all reporting groups

Baseline Measures
    Dabigatran Etexilate 220 mg - Part 1     Ticagrelor 180 mg - Part 1     Dabigatran Etexilate 220 mg - Part 2     Ticagrelor 180 mg - Part 2     Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3     Total  
Number of Participants  
[units: participants]
  8     4     8     4     12     36  
Age  
[units: years]
Mean ± Standard Deviation
  30.6  ± 7.7     29.8  ± 11.4     33.6  ± 9.1     33.3  ± 6.3     30.2  ± 7.2     31.3  ± 8.2  
Gender  
[units: participants]
           
Female     0     0     0     0     0     0  
Male     8     4     8     4     12     36  



  Outcome Measures
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1.  Primary:   Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)   [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]

2.  Primary:   Total Dabigatran: Maximum Measured Concentration (Cmax)   [ Time Frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours ]

3.  Secondary:   Number of Participants With Drug Related Adverse Events   [ Time Frame: From screening until the end-of-study examination ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01595854     History of Changes
Other Study ID Numbers: 1160.141, 2012-000874-42
Study First Received: May 9, 2012
Results First Received: June 18, 2013
Last Updated: June 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices