Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects

Healthy Clinical Trial

Official title:

A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02084810
• Other study ID #: NN7777-4087
• Secondary ID: 2013-003163-63U1
• Status: Withdrawn
• Phase: Phase 1
• First received: January 28, 2014
• Last updated: March 24, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male, age 18-55 years, both inclusive, at the time of signing informed consent

• Body Mass Index (BMI) 18.5-30 kg/m^2, both inclusive

• Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator

Exclusion Criteria:

• Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• activated recombinant human factor VII
All subjects will receive one i.v. (intravenous, into the vein) injection of 90µg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
• eptacog alfa (activated)
All subjects will receive one i.v. injection of 90µg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve		After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose	No
Primary	Maximum concentration		After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose	No
Secondary	Frequency of adverse events (including serious adverse events)		Assessed up to 7 weeks following first trial product administration	No
Secondary	Incidence of antibodies		Assessed up to 7 weeks following first trial product administration	No

External Links

•   Clinical Trials at Novo Nordisk