Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBR 1048 MS + Pantoprazole

Drug: BIBR 1048 MS - high dose

Drug: BIBR 1048 MS - low dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02170740

1160.14

Details and patient eligibility

About

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.

Enrollment

26 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects as determined by results of screening
Signed written informed consent in accordance with GCP and local legislation
Age ≥ 18 and ≤ 50 years
Broca ≥ - 20% and ≤ + 20%

Exclusion criteria

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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 and 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
History of any bleeding disorder including prolonged or habitual bleeding
History of other hematologic disease
History of cerebral bleeding (e.g. after a car accident)
History of commotio cerebri
Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
Participation in another trial with investigational drug within 2 months prior to administration or during the trial
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
Alcohol abuse (> 60g/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 familiar bleeding disorder
Thrombocytes < 150000/µl