search
Back to results

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)

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Healthy

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NNC172-2021
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose (healthy subjects)

Medium dose (subjects with haemophilia)

High dose (subjects with haemophilia)

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events (AEs)

Secondary Outcome Measures

Local tolerability
Thrombocyte count
Trough level (Ctrough)

Full Information

First Posted
June 28, 2012
Last Updated
May 14, 2019
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01631942
Brief Title
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
Acronym
explorer™2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
See detailed description
Study Start Date
June 26, 2012 (Actual)
Primary Completion Date
September 4, 2012 (Actual)
Study Completion Date
September 4, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose (healthy subjects)
Arm Type
Experimental
Arm Title
Medium dose (subjects with haemophilia)
Arm Type
Experimental
Arm Title
High dose (subjects with haemophilia)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC172-2021
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of adverse events (AEs)
Time Frame
From first trial drug administration through trial day 35
Secondary Outcome Measure Information:
Title
Local tolerability
Time Frame
After the last s.c. dose administration (trial day 15)
Title
Thrombocyte count
Time Frame
After the last s.c. dose administration (trial day 15)
Title
Trough level (Ctrough)
Time Frame
Prior to the last s.c. dose administration (trial day 15)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

We'll reach out to this number within 24 hrs