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

Novo Nordisk

Status and phase: Withdrawn; Phase 1

Conditions: Healthy; Haemophilia B With Inhibitors; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: eptacog alfa (activated); Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084810

U1111-1145-6620 (Other Identifier)

NN7777-4087

2013-003163-63 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups

NovoSeven®

Active Comparator group

Treatment:

Drug: activated recombinant human factor VII

Eptacog alfa A 6 mg

Experimental group

Treatment:

Drug: eptacog alfa (activated)