Status:
COMPLETED
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administer...
Eligibility Criteria
Inclusion
- Caucasian origin
- Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
- Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)
Exclusion
- Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
- Previous participation in this trial, defined as randomised to receive trial product
- Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
- Known history of atherosclerosis or thromboembolic events
- Overt bleeding, including from gastrointestinal tract
- Hepatitis B or C infection
- HIV infection
- Positive test for drugs of abuse
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00951873
Start Date
July 1 2009
End Date
April 1 2010
Last Update
May 13 2016
Active Locations (1)
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1
Harrow, United Kingdom, HA1 3UJ