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Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555749
First Posted: March 15, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
March 13, 2012
March 15, 2012
February 27, 2017
March 12, 2012
May 8, 2012   (Final data collection date for primary outcome measure)
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 [ Time Frame: Week 5 ]
Same as current
Complete list of historical versions of study NCT01555749 on ClinicalTrials.gov Archive Site
  • Maximal concentration of NNC172-2021 (Cmax) [ Time Frame: Week 5 ]
  • Time point for maximal concentration (tmax) [ Time Frame: Week 5 ]
  • Terminal half-life (t1/2) [ Time Frame: Week 5 ]
  • Number of adverse events (AEs) [ Time Frame: Week 5 ]
  • Presence of antibodies against NNC172-2021 [ Time Frame: Week 5 ]
  • Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation [ Time Frame: Week 5 ]
  • TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Week 5 ]
Same as current
Not Provided
Not Provided
 
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
  • Healthy
  • Drug: NNC172-2021
    One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
  • Drug: placebo
    One injection administered subcutaneously (s.c., under the skin)
  • Experimental: NNC172-2021 low dose / Placebo
    Interventions:
    • Drug: NNC172-2021
    • Drug: placebo
  • Experimental: NNC172-2021 high dose / Placebo
    Interventions:
    • Drug: NNC172-2021
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 8, 2012
May 8, 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
20 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01555749
NN7415-3981
2011-004575-36 ( EudraCT Number )
U1111-1124-5137 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP