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

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01631942
• Other study ID #: NN7415-3986
• Secondary ID: 2011-005757-32U1
• Status: Terminated
• Phase: Phase 1
• Start date: June 26, 2012
• Est. completion date: September 4, 2012

Study information

• Verified date: May 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 4, 2012
• Est. primary completion date: September 4, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Healthy
• Hemophilia A
• Hemostatic Disorders

Intervention

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.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Wien
France	Novo Nordisk Investigational Site	Lyon
France	Novo Nordisk Investigational Site	Montpellier
Germany	Novo Nordisk Investigational Site	Berlin
Spain	Novo Nordisk Investigational Site	Madrid
United Kingdom	Novo Nordisk Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  France,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

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):

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events (AEs)		From first trial drug administration through trial day 35
Secondary	Local tolerability		After the last s.c. dose administration (trial day 15)
Secondary	Thrombocyte count		After the last s.c. dose administration (trial day 15)
Secondary	Trough level (Ctrough)		Prior to the last s.c. dose administration (trial day 15)

External Links

•   Clinical Trials at Novo Nordisk