Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran high dose; Drug: Dabigatran low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171468

1160.61

Details and patient eligibility

About

To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Japanese or Caucasian healthy male subjects according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests

   • No finding of clinical relevance
   • No evidence of a clinically relevant concomitant disease
   • Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan

2. Age: ≥20 and ≤45 years

3. Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2

4. Signed and dated written informed consent before admission to the trial site

Exclusion criteria

1. Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

2. Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination

3. Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders

4. History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts

5. Chronic or relevant acute infections

6. History of

   • allergy/hypersensitivity (including drug allergy) which is deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
   • any bleeding disorder including prolonged or habitual bleeding
   • other hematologic diseases
   • cerebral bleeding (e.g. after a car accident)
   • concussions (head trauma resulting in injuring to brain) with or without loss of consciousness

7. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial

8. Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 days prior to administration up to end-of-study examination

9. Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination

10. Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial)

11. Alcohol abuse (more than 60 g/day; confirmed by interview)

12. Drug abuse (confirmed by interview)

13. Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination)

14. Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination)

15. Any laboratory value outside the reference range that is of clinical relevance

16. Known hypersensitivity to the investigational drug or its excipients

17. Subject who was judged ineligible by the investigator or the sub-investigator

18. History of any familial bleeding disorder

19. Thrombocytes <15 x 10**4 /microL

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Dabigatran high dose

Experimental group

Treatment:

Drug: Dabigatran high dose

Dabigatran low dose

Experimental group

Treatment:

Drug: Dabigatran low dose