Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
Phase 1
Withdrawn
- Conditions
- Congenital Bleeding DisorderHaemophilia AHaemophilia A With InhibitorsHaemophilia BHaemophilia B With InhibitorsHealthy
- Interventions
- Drug: activated recombinant human factor VII
- Registration Number
- NCT02084810
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Male, age 18-55 years, both inclusive, at the time of signing informed consent
- Body Mass Index (BMI) 18.5-30 kg/m^2, both inclusive
- Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator
Exclusion Criteria
- Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NovoSeven® activated recombinant human factor VII - Eptacog alfa A 6 mg eptacog alfa (activated) -
- Primary Outcome Measures
Name Time Method Area under the curve After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose Maximum concentration After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
- Secondary Outcome Measures
Name Time Method Frequency of adverse events (including serious adverse events) Assessed up to 7 weeks following first trial product administration Incidence of antibodies Assessed up to 7 weeks following first trial product administration