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Completed

NCT Number: NCT01561417

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

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).

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Key information

Conditions

Acquired Bleeding Disorder Acquired Haemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Congenital Bleeding Disorder Congenital FVII Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glanzmann's Disease Haemophilia A With Inhibitors Haemophilia B With Inhibitors Healthy Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Thrombasthenia

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

One single dose administration, injected i.v. (into the vein)

Primary outcomes

  1. Area under the plasma concentration versus time curve for FVIIa clot activity

Secondary outcomes

  1. The maximum plasma concentration (Cmax)

  2. Terminal half-life (t½)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 23, 2012
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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