Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Acquired Bleeding Disorder; Acquired Haemophilia; Glanzmann's Disease; Healthy; Congenital FVII Deficiency; Haemophilia B With Inhibitors
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01561417
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CP-rFVIIa	activated recombinant human factor VII	-
VII25	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve for FVIIa clot activity

Secondary Outcome Measures

Name	Time	Method
Terminal half-life (t½)
The maximum plasma concentration (Cmax)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris, France