Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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 Criteria

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

Exclusion Criteria

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

Locations

Vienna, 1090
Vienna, 1090

Tracking Information

NCT #
NCT02080858
Collaborators
Not Provided
Investigators
Not Provided