Status:
COMPLETED
Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02259881
Start Date
December 1 2002
Last Update
October 9 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.