Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563471
First received: March 23, 2012
Last updated: June 26, 2012
Last verified: March 2012
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy
Drug: activated recombinant human factor VII
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) [ Designated as safety issue: No ]
  • Time to reach maximum plasma concentration (tmax) [ Designated as safety issue: No ]
  • Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2001
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence 1 Drug: activated recombinant human factor VII
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Drug: placebo
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Experimental: Treatment sequence 2 Drug: activated recombinant human factor VII
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Drug: placebo
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Experimental: Treatment sequence 3 Drug: activated recombinant human factor VII
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Drug: placebo
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Placebo Comparator: Treatment sequence 4 Drug: activated recombinant human factor VII
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Drug: placebo
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian or Japanese
  • Healthy as defined by medical history, physical and biological examinations

Exclusion Criteria:

  • History of allergy or hypersensitivity reaction to any medication
  • History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
  • Alcohol or substance abuse disorder
  • Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563471

Locations
France
Paris, France, 75015
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marianne J. Fridberg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563471     History of Changes
Other Study ID Numbers: F7LIVER-1465
Study First Received: March 23, 2012
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014