NCT01561417CompletedPhase 1
A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve for FVIIa clot activity
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Caucasian
- •Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
- •Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
- •Smoke less than 10 cigarettes (or equivalent) per day
- •Capable of giving written Informed Consent (IC)
Exclusion Criteria
- •Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
- •Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
- •Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
- •Overt bleeding, including from gastrointestinal tract
- •Hepatitis (B or C) infection
- •HIV (human immunodeficiency virus) infection
Arms & Interventions
CP-rFVIIa
Active Comparator
Intervention: activated recombinant human factor VII (Drug)
VII25
Experimental
Intervention: activated recombinant human factor VII (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary Outcomes
- The maximum plasma concentration (Cmax)
- Terminal half-life (t½)
Investigators
Study Sites (1)
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