A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects (explorer™2)

May 14, 2019 updated by: Novo Nordisk A/S
This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.

Study Type

Interventional

Enrollment (Actual)

4

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

  • Austria
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
  • France
      • Lyon, France, 69003
        • Novo Nordisk Investigational Site
      • Montpellier, France, 34295
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Novo Nordisk Investigational Site

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Thrombocyte count below the lower limit of normal range at screening
  • Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose (healthy subjects)
Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.
Experimental: Medium dose (subjects with haemophilia)
Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.
Experimental: High dose (subjects with haemophilia)
Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: From first trial drug administration through trial day 35
From first trial drug administration through trial day 35

Secondary Outcome Measures

Outcome Measure
Time Frame
Local tolerability
Time Frame: After the last s.c. dose administration (trial day 15)
After the last s.c. dose administration (trial day 15)
Thrombocyte count
Time Frame: After the last s.c. dose administration (trial day 15)
After the last s.c. dose administration (trial day 15)
Trough level (Ctrough)
Time Frame: Prior to the last s.c. dose administration (trial day 15)
Prior to the last s.c. dose administration (trial day 15)

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.

General Publications

  • Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)

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 (Actual)

June 26, 2012

Primary Completion (Actual)

September 4, 2012

Study Completion (Actual)

September 4, 2012

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7415-3986
  • 2011-005757-32 (EudraCT Number)
  • U1111-1126-0327 (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.

Clinical Trials on Healthy

Clinical Trials on NNC172-2021

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe