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

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®

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Haemophilia A; Haemophilia B
• Intervention / Treatment: Drug: activated recombinant human factor VII; Drug: eptacog alfa (activated)

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NovoSeven®	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.
Experimental: Eptacog alfa A 6 mg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve	After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Maximum concentration	After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events (including serious adverse events)	Assessed up to 7 weeks following first trial product administration
Incidence of antibodies	Assessed up to 7 weeks following first trial product administration

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
• Other Study ID Numbers: NN7777-4087; 2013-003163-63 (EudraCT Number); U1111-1145-6620 (Other Identifier: WHO)