Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects

NCT ID: NCT02171000

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

Brief Summary

To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days)

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBR 1048

BIBR 1048 MS

Group Type: EXPERIMENTAL

BIBR 1048 MS

Intervention Type: DRUG

150 mg capsules, b.i.d, 7 days

Interventions

BIBR 1048 MS

150 mg capsules, b.i.d, 7 days

Intervention Type: DRUG

Other Intervention Names

dabigatran etexilate

Eligibility Criteria

Inclusion Criteria

1. 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 ECG, clinical laboratory tests

• 1.1 No finding of clinical relevance
• 1.2 No evidence of a clinically relevant concomitant disease

2. Age ≥20 and Age ≤35 years

3. Body Mass Index (BMI) ≥18 and BMI <25 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the trial in accordance with Japanese GCP (Ministry of Health, Labour and Welfare Ordinance No.28, March 27, 1997).

Exclusion Criteria

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

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

3. Diseases of the central nervous system (such as epilepsy), 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 was 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 was shorter, of the respective drug prior to administration or during the trial

8. Use of aspirin (including over-the-counter medications), antiplatelet agents like ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs, coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 14 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 was 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 104 /μL

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.55

Identifier Type: -

Identifier Source: org_study_id