Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02080858
Collaborators
Not Provided
Investigators
Not Provided