Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Thromboplastin

Criteria

Inclusion Criteria:

• Healthy male subjects as determined by the screening procedure

• Signed written informed consent form in accordance with good clinical practice (GCP) and local legislation was available

• Age ≥ 18 and ≤ 40 years

• Body mass index: BMI ≥ 18 and ≤ 29.9 kg/m2

• Normal findings in medical history and physical examination unless the investigator considered an abnormality to be clinically irrelevant

• Normal laboratory parameters unless the investigator considered an abnormality to be clinically irrelevant

Exclusion Criteria:

• Any finding in the medical examination (including blood pressure, pulse rate, ECG, and laboratory parameters) deviating from normal and of clinical relevance

• History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), or psychiatric disorders

• Symptoms of a clinically relevant illness in the 3 weeks before the first trial day

• History of orthostatic hypotension, fainting spells, and blackouts

• Chronic or relevant acute infections

• History of allergy / hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator

• History of

• any bleeding disorder including prolonged or habitual bleeding

• any familial bleeding disorder

• other haematological disease

• cerebral bleeding (e.g. after a car accident)

• commotio cerebri

• Hereditary deficiency of protein C or S, or a mutation of factor V (Leiden), or any other known abnormality affecting coagulation, fibrinolysis, or platelet function

• Platelet count < 150000/μL

• Any ECG value outside of the reference range of clinical relevance (QRS interval > 110 ms or QTcB (QT interval Bazett correction) > 450 ms will be an obligatory exclusion criterion)

• Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration

• Use of any drugs that 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

• Participation in an LPS trial within the last six weeks

• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

• Concurrent or history of drug, alcohol, tobacco or coffee / tea / cola 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

• Seropositivity for hepatitis B surface antigen (HBs-Ag), hepatitis C virus (HCV), HIV 1, or HIV 2 antibodies

• Weight over 95 kg