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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01555749
First received: March 13, 2012
Last updated: May 22, 2012
Last verified: May 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal concentration of NNC172-2021 (Cmax) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Time point for maximal concentration (tmax) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Terminal half-life (t1/2) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Presence of antibodies against NNC172-2021 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555749

Locations
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mia Lundblad Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01555749     History of Changes
Other Study ID Numbers: NN7415-3981, 2011-004575-36, U1111-1124-5137
Study First Received: March 13, 2012
Last Updated: May 22, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 17, 2014