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.

Study Overview

• Status: Completed
• Conditions: Healthy; Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
• Intervention / Treatment: Drug: NNC172-2021; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021	Week 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximal concentration of NNC172-2021 (Cmax)	Week 5
Time point for maximal concentration (tmax)	Week 5
Terminal half-life (t1/2)	Week 5
Number of adverse events (AEs)	Week 5
Presence of antibodies against NNC172-2021	Week 5
Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation	Week 5
TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)	Week 5

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2012
• Primary Completion (Actual): May 8, 2012
• Study Completion (Actual): May 8, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
• Other Study ID Numbers: NN7415-3981; 2011-004575-36 (EudraCT Number); U1111-1124-5137 (Other Identifier: WHO)