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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBT 986 BS - low

Drug: BIBT 986 BS - high

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02254083

1192.2

Details and patient eligibility

About

Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters

Enrollment

16 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
Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes < 150000/μl (two repeats of the first test)
Evidence of hematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no more than one repeated test)
Evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, Central nervous system (CNS) trauma, retinopathy, nephrolithiasis)
Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
Use of any drugs, within 14 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
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
Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)