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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563471
First Posted: March 27, 2012
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
March 23, 2012
March 27, 2012
January 13, 2017
October 2001
July 2002   (Final data collection date for primary outcome measure)
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
Same as current
Complete list of historical versions of study NCT01563471 on ClinicalTrials.gov Archive Site
  • Mean residence time (MRT)
  • Maximum plasma concentration (Cmax)
  • Time to reach maximum plasma concentration (tmax)
  • Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
  • Adverse events
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
  • Healthy
  • 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 1
    Interventions:
    • Drug: activated recombinant human factor VII
    • Drug: placebo
  • Experimental: Treatment sequence 2
    Interventions:
    • Drug: activated recombinant human factor VII
    • Drug: placebo
  • Experimental: Treatment sequence 3
    Interventions:
    • Drug: activated recombinant human factor VII
    • Drug: placebo
  • Placebo Comparator: Treatment sequence 4
    Interventions:
    • Drug: activated recombinant human factor VII
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2002
July 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01563471
F7LIVER-1465
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP