Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02080858
Collaborators
Not Provided
Investigators
Not Provided
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