Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran etexilate high; Drug: Dabigatran etexilate low; Drug: Moxifloxacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170987

1160.54

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Dabigatran etexilate low

Experimental group

Treatment:

Drug: Dabigatran etexilate low

Dabigatran etexilate high

Experimental group

Treatment:

Drug: Dabigatran etexilate high

Placebo to dabigatran etexilate

Placebo Comparator group

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin