Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

August 19, 2014 updated by: Novo Nordisk A/S

A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body weight between 50.0 and 100.0 kg, both inclusive
  • Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
  • Any clinical sign or known history of atherosclerosis or thromboembolic events
  • Renal dysfunction
  • A subject considered at high risk of thromboembolic events
  • Overt bleeding, including from gastrointestinal tract
  • Hepatitis B or C infection
  • Human immunodeficiency virus (HIV) infection
  • Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
  • Smoking within 3 months prior to trial start
  • Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
  • Excessive consumption of a diet deviating from a normal diet
  • Blood donation within the last three months prior to screening
  • The receipt of any investigational product within 30 days of trial product administration
  • Participation in any other trial investigating a procoagulant within the last six months prior to screening
  • Strenuous exercise within four days prior trial start
  • Suffers from a life threatening disease
  • Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
  • Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
  • Subjects with high fasting cholesterol at trial start

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
Experimental: A
Drug: NNC 0128-0000-2011
Administered as one single i.v. (intravenous) injection, 100 mcg/kg
Experimental: B
Drug: NNC 0128-0000-2021
Administered as one single i.v. (intravenous) injection, 100 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse events (AEs)
Time Frame: from first trial product administration until maximally 10 weeks after last trial product administration
from first trial product administration until maximally 10 weeks after last trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Neutralising antibodies against FVII and/or N7-GP
Time Frame: from first trial product administration until maximally 10 weeks after last trial product administration
from first trial product administration until maximally 10 weeks after last 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

January 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7128-3729
  • 2010-021286-67 (EudraCT Number)
  • U1111-1118-0208 (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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