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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)

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ClinicalTrials.gov Identifier: NCT01631942
Recruitment Status : Terminated (See detailed description)
First Posted : June 29, 2012
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Healthy Drug: NNC172-2021 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 26, 2012
Actual Primary Completion Date : September 4, 2012
Actual Study Completion Date : September 4, 2012

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events (AEs) [ Time Frame: From first trial drug administration through trial day 35 ]

Secondary Outcome Measures :
  1. Local tolerability [ Time Frame: After the last s.c. dose administration (trial day 15) ]
  2. Thrombocyte count [ Time Frame: After the last s.c. dose administration (trial day 15) ]
  3. Trough level (Ctrough) [ Time Frame: Prior to the last s.c. dose administration (trial day 15) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631942


Locations
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Austria
Novo Nordisk Investigational Site
Wien, Austria, 1090
France
Novo Nordisk Investigational Site
Lyon, France, 69003
Novo Nordisk Investigational Site
Montpellier, France, 34295
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
United Kingdom
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
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)

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01631942    
Other Study ID Numbers: NN7415-3986
2011-005757-32 ( EudraCT Number )
U1111-1126-0327 ( Other Identifier: WHO )
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases