Brief Title
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
Official Title
A Randomised, Double-blind, Placebo-controlled, Single Centre, Single Dose Trial, Assessing the Pharmacokinetics of NNC172-2021, Administered Subcutaneously at Two Different Dose Levels, in Healthy Japanese Subjects
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the
pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered
subcutaneously, at two different dose levels, in healthy Japanese subjects.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
Secondary Outcome
Maximal concentration of NNC172-2021 (Cmax)
Condition
Congenital Bleeding Disorder
Intervention
NNC172-2021
Study Arms / Comparison Groups
NNC172-2021 low dose / Placebo
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
8
Start Date
March 12, 2012
Completion Date
May 8, 2012
Primary Completion Date
May 8, 2012
Eligibility Criteria
Inclusion Criteria:
- Healthy male Japanese subjects defined as: Subjects born in Japan, time residing
outside of Japan does not exceed 5 years, both parents and all 4 grandparents of
Japanese descent
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 and 30.0 kg/m^2, both inclusive
Exclusion Criteria:
- Male subjects who are sexually active and not surgically sterilised who, or whose
partner, are unwilling to use two different forms of effective contraception, one of
which has to be a barrier method of contraception (e.g. condom with spermicidal
foam/gel/film/cream) for the duration of the trial and for 3 months following the last
dose of trial medication
- Planned surgery 30 days prior to trial product administration and/or during the entire
trial period
- Known hepatic dysfunction during the last 12 months prior to screening (Visit 1)
- Positive urine test for drugs of abuse
- Active hepatitis B and/or hepatitis C infection
- Positive for human immunodeficiency virus (HIV)
- Subjects with clinical signs of thromboembolic events, considered to be at high risk
of thromboembolic event or subjects with a known first degree family history of
thromboembolism
- Participation in any other trial investigating other products or involving blood
sampling within the last 30 days prior to screening
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid
(ASA), but not ibuprofen and cyclooxygenase-2 (COX-2) specific inhibitors within 2
weeks prior to trial product administration (Visit 2)
- Positive alcohol test at screening (Visit 1) and/or history of alcohol or drug abuse
within the last 12 months prior to screening (Visit 1)
- Smokers; defined as tobacco users smoking more than 5 cigarettes per day or the
corresponding amount of tobacco consumption
- Blood donation within the last 3 months prior to screening and/or during the entire
trial period
- Strenuous exercise (as judged by the trial physician) within the last 4 days prior to
screening (Visit 1)
Gender
Male
Ages
20 Years - 64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01555749
Organization ID
NN7415-3981
Secondary IDs
2011-004575-36
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
February 2017