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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01555749
First received: March 13, 2012
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy Drug: NNC172-2021 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 [ Time Frame: Week 5 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Actual Study Start Date: March 12, 2012
Study Completion Date: May 8, 2012
Primary Completion Date: May 8, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC172-2021 low dose / Placebo 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 high dose / Placebo 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)

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555749

Locations
United Kingdom
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01555749     History of Changes
Other Study ID Numbers: NN7415-3981
2011-004575-36 ( EudraCT Number )
U1111-1124-5137 ( Other Identifier: WHO )
Study First Received: March 13, 2012
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017