Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) i...
Eligibility Criteria
Inclusion
- Japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator or Sub-investigator
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (inclusive)
Exclusion
- Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the Investigator or Sub-investigator
- Presence or history of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- Evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the Investigator or Sub-investigator
- Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events
- Any past history of migraine
- Overt bleeding, including from the gastrointestinal tract
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00822185
Start Date
January 1 2009
End Date
July 1 2009
Last Update
January 5 2015
Active Locations (1)
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1
Tokyo, Japan, 130-0004