Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
2 other identifiers
interventional
36
1 country
1
Brief Summary
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2012
Shorter than P25 for phase_1 healthy
1 active site
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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
August 22, 2013
CompletedAugust 22, 2013
June 1, 2013
1 month
May 9, 2012
June 18, 2013
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Total Dabigatran: Maximum Measured Concentration (Cmax)
Maximum measured concentration of total dabigatran in plasma, per period.
-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary Outcomes (1)
Number of Participants With Drug Related Adverse Events
From screening until the end-of-study examination
Study Arms (4)
Test 2 (part 3)
EXPERIMENTALlow dose dabigatran + high dose ticagrelor
Test 1 (part 1 + 2)
ACTIVE COMPARATORhigh dose ticagrelor
Reference 1 (part 1 + 2)
EXPERIMENTALmedium dose dabigatran
Reference 2 (part 3)
EXPERIMENTALlow dose dabigatran
Interventions
Eligibility Criteria
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)
1160.141.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 10, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 22, 2013
Results First Posted
August 22, 2013
Record last verified: 2013-06