Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02080858
Collaborators
Not Provided
Investigators
Not Provided