Healthy
Conditions
Brief summary
To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters prior to administration of a high dose of dabigatran etexilate in a QT study
Interventions
DRUGDabigatran etexilate medium dose
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests 2. Age ≥18 and ≤55 years 3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Exclusion criteria
1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 2. Relevant surgery of gastrointestinal tract 3. History of any bleeding disorder or acute blood coagulation defect 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. History of relevant orthostatic hypotension, fainting spells or blackouts 6. Chronic or relevant acute infections 7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator 8. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial 10. Participation in another trial with an investigational drug within two months prior to administration or during the trial 11. Alcohol abuse (more than 60 g/day) 12. Drug abuse 13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 14. Excessive physical activities (within one week prior to administration or during the trial) 15. Any laboratory value outside the reference range that is of clinical relevance 16. Inability to comply with dietary regimen of study centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency [N (%)] of subjects with adverse events | up to 18 days |
Secondary
| Measure | Time frame |
|---|---|
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 72 hours after administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 72 hours after administration |
| Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma) | up to 72 hours after administration |
| tmax (time from dosing to maximum measured concentration) | up to 72 hours after administration |
| AUC0-∞ (area under the concentration-time curve of free and total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours after administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 72 hours after administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 72 hours after administration |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 72 hours after administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after administration |
| λz (terminal rate constant in plasma) | up to 72 hours after administration |
Outcome results
None listed