Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers

NCT ID: NCT02170116

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30

Brief Summary

The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIBR 1048 MS dose 1

Group Type: EXPERIMENTAL

BIBR 1048 MS dose 1

Intervention Type: DRUG

BIBR 1048 MS dose 2

Group Type: EXPERIMENTAL

BIBR 1048 MS dose 2

Intervention Type: DRUG

BIBR 1048 MS dose 3

Group Type: EXPERIMENTAL

BIBR 1048 MS dose 3

Intervention Type: DRUG

BIBR 1048 MS dose 4

Group Type: EXPERIMENTAL

BIBR 1048 MS dose 4

Intervention Type: DRUG

BIBR 1048 MS dose 5

Group Type: EXPERIMENTAL

BIBR 1048 MS dose 5

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo to BIBR 1048 MS

Intervention Type: DRUG

Interventions

BIBR 1048 MS dose 1

Intervention Type: DRUG

BIBR 1048 MS dose 2

Intervention Type: DRUG

BIBR 1048 MS dose 3

Intervention Type: DRUG

BIBR 1048 MS dose 4

Intervention Type: DRUG

BIBR 1048 MS dose 5

Intervention Type: DRUG

Placebo to BIBR 1048 MS

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 45 years
• Broca >= - 20 % and <= + 20 %

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of

• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic disease
• cerebral bleeding (e.g. after a car accident)
• commotion cerebri
• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range
• History of any familial bleeding disorder
• Thrombocytes < 150000/µl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.1

Identifier Type: -

Identifier Source: org_study_id