Clinical trial NCT02170987: Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.
Official title: Assessment of Electrophysiological Effects of 150 mg and 600 mg of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind Three-way Crossover Study With an Open Label Positive Control (Moxifloxacin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean time-matched QTc Interval
timeFrame: at 1.5, 2, and 3 hours following administration
Secondary outcomes:
measure: Mean of the QTcI values of all ECGs
timeFrame: from 1 to 6 hours following administration
measure: Change from baseline of the QTcI
timeFrame: from 1 to 24 hours following administration
Other outcomes:
Locations:
Study officials:
References: