Healthy
Conditions
Brief summary
To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female (at least 1/3) and male (at least 1/3) volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests 2. Age \>= 18 and Age \<= 65 years 3. BMI \>= 20.0 and BMI \<=29.9 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
1. Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients) 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. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) 12. Inability to refrain from smoking on trial days 13. Alcohol abuse (more than 60 g/day) 14. Drug abuse 15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 16. History of any bleeding disorder or acute blood coagulation defect 17. Hypersensitivity to moxifloxacin and/or related drugs of this class 18. Excessive physical activities (within one week prior to administration or during the trial) 19. Any laboratory value outside the reference range that is of clinical relevance 20. Inability to comply with dietary regimen of study centre 21. History of additional risk factors for Torsade des Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome) 22. Any screening ECG value outside of the reference range of clinical relevance including, but not limited to heart rate of \>80 bpm or \<45 bpm, PR interval \>220 ms, QRS interval \>120 ms, QT interval \>470 ms or QTcB or QTcF \>450 ms For female subjects: 23. Pregnancy 24. Positive pregnancy test 25. No adequate contraception e.g. oral contraceptives, sterilisation, intrauterine device (IUD) 26. Inability to maintain this adequate contraception during the whole study period 27. Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean time-matched QTc Interval | at 1.5, 2, and 3 hours following administration |
Secondary
| Measure | Time frame |
|---|---|
| Mean of the QTcI values of all ECGs | from 1 to 6 hours following administration |
| Change from baseline of the QTcI | from 1 to 24 hours following administration |
Outcome results
None listed