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

NCT02084810 | Withdrawn Phase 1

• 3 other identifiers: NN7777-40872013-003163-63U1111-1145-6620
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

NovoSeven®

ACTIVE COMPARATOR

Drug: activated recombinant human factor VII

Eptacog alfa A 6 mg

EXPERIMENTAL

Drug: eptacog alfa (activated)

Interventions

activated recombinant human factor VII DRUG

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.

NovoSeven®

eptacog alfa (activated) DRUG

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.

Eptacog alfa A 6 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Interventions

Factor VII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: March 12, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03