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
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of adverse events (AEs)
Secondary Outcome
Local tolerability
Condition
Congenital Bleeding Disorder
Intervention
NNC172-2021
Study Arms / Comparison Groups
Low dose (healthy subjects)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
4
Start Date
June 26, 2012
Completion Date
September 4, 2012
Primary Completion Date
September 4, 2012
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
Gender
Male
Ages
18 Years - 64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01631942
Organization ID
NN7415-3986
Secondary IDs
2011-005757-32
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
May 2019