Recruitment

Recruitment Status
Completed

Inclusion Criterias

Normal findings in medical & bleeding history
Non-smoking behaviour
Healthy male subjects; 18 - 40 years of age
...
Normal findings in medical & bleeding history
Non-smoking behaviour
Healthy male subjects; 18 - 40 years of age
body mass index between 18 and 27 kg/m2
Written informed consent

Exclusion Criterias

Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
Known allergy against test agents
...
Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
Known allergy against test agents
Known sensitivity to common causes of bleeding (e.g. nasal)
Participation in another clinical trial during the preceding 3 weeks
Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
History of thromboembolism
Anaemia (defined as haemoglobin levels < LLN)
Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
Impaired renal function (serum creatinine > 1.3 mg/dl)
Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration
Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
Impaired liver function (AST, ALT, GGT >2 x ULN, Bilirubin >1.5 x ULN)

Summary

Conditions
  • Acute Coronary Syndrome
  • Atrial Fibrillation
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only males

Inclusion Criterias

Normal findings in medical & bleeding history
Non-smoking behaviour
Healthy male subjects; 18 - 40 years of age
...
Normal findings in medical & bleeding history
Non-smoking behaviour
Healthy male subjects; 18 - 40 years of age
body mass index between 18 and 27 kg/m2
Written informed consent

Exclusion Criterias

Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
Known allergy against test agents
...
Known disorders with increased bleeding risk (e.g. peridontitis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
Known allergy against test agents
Known sensitivity to common causes of bleeding (e.g. nasal)
Participation in another clinical trial during the preceding 3 weeks
Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
History of thromboembolism
Anaemia (defined as haemoglobin levels < LLN)
Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
Impaired renal function (serum creatinine > 1.3 mg/dl)
Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration
Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
Impaired liver function (AST, ALT, GGT >2 x ULN, Bilirubin >1.5 x ULN)

Locations

Vienna, 1090
Vienna, 1090

Tracking Information

NCT #
NCT02080858
Collaborators
Not Provided
Investigators
Not Provided