Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BIBT 986 BS - single rising dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02254057

1192.1

Details and patient eligibility

About

Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters

Enrollment

47 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 <= 55 years
BMI >= 18.5 and <= 29.9 kg/m2

Exclusion criteria

Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Relevant history of orthostatic hypotension, fainting spells or blackouts
Any bleeding disorder including prolonged or habitual bleeding
History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Seasonal rhinitis
Thrombocytes < 150000/μl
Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
Use of any drugs, which might influence the results of the trial (< 10 days prior to administration or during the trial)
Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
Alcohol abuse (> 60 g/day)
Drug abuse
Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug or during trial
Blood donation or loss > 400 ml, < 1 month prior to administration or during the trial
Excessive physical activities < 5 days prior to administration of study drug or during trial
Clinically relevant laboratory abnormalities
Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms
Inability to comply with dietary regimen of study centre
Inability to comply with investigator's instructions