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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563471
• Other study ID #: F7LIVER-1465
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2012
• Last updated: January 12, 2017
• Start date: October 2001
• Est. completion date: July 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Healthy
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

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
• 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

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (2)

Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66. — View Citation

Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
Secondary	Mean residence time (MRT)
Secondary	Maximum plasma concentration (Cmax)
Secondary	Time to reach maximum plasma concentration (tmax)
Secondary	Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk