A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

May 12, 2016 updated by: Novo Nordisk A/S

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasian origin
  • Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
  • Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
  • Previous participation in this trial, defined as randomised to receive trial product
  • Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
  • Known history of atherosclerosis or thromboembolic events
  • Overt bleeding, including from gastrointestinal tract
  • Hepatitis B or C infection
  • HIV infection
  • Positive test for drugs of abuse

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: activated recombinant human factor VII, long acting
Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Drug: activated recombinant human factor VII, long acting
Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).
Experimental: C
Drug: activated recombinant human factor VII, long acting
Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Drug: activated recombinant human factor VII, long acting
Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).
Placebo Comparator: B
Drug: placebo
Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: assessed throughout the trial period from visit 1 to visit 5
assessed throughout the trial period from visit 1 to visit 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under activity concentration-time curve from time zero to infinity
Time Frame: assessed up to 168 hours after trial product administration
assessed up to 168 hours after 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

July 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

July 31, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7129-3754
  • 2009-011267-37 (EudraCT Number)

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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