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

March 24, 2014 updated by: Novo Nordisk A/S

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Maximum concentration
Time Frame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
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)
Time Frame: Assessed up to 7 weeks following first trial product administration
Assessed up to 7 weeks following first trial product administration
Incidence of antibodies
Time Frame: Assessed up to 7 weeks following first trial product administration
Assessed up to 7 weeks following first trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • NN7777-4087
  • 2013-003163-63 (EudraCT Number)
  • U1111-1145-6620 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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