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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

activated recombinant human factor VII

eptacog alfa (activated)

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NovoSeven®

Eptacog alfa A 6 mg

Arm Description

Outcomes

Primary Outcome Measures

Area under the curve

Maximum concentration

Secondary Outcome Measures

Frequency of adverse events (including serious adverse events)

Incidence of antibodies

Full Information

NCT ID

NCT02084810

First Posted

January 28, 2014

Last Updated

March 24, 2014

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02084810

Brief Title

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

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®

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Withdrawn

Study Start Date

March 2014 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NovoSeven®

Arm Type

Active Comparator

Arm Title

Eptacog alfa A 6 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

activated recombinant human factor VII

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

eptacog alfa (activated)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Area under the curve

Time Frame

After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose

Title

Maximum concentration

Time Frame

After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose

Secondary Outcome Measure Information:

Title

Frequency of adverse events (including serious adverse events)

Time Frame

Assessed up to 7 weeks following first trial product administration

Title

Incidence of antibodies

Time Frame

Assessed up to 7 weeks following first trial product administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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