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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NNC172-2021

placebo

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

20 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NNC172-2021 low dose / Placebo

NNC172-2021 high dose / Placebo

Arm Description

Outcomes

Primary Outcome Measures

Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021

Secondary Outcome Measures

Maximal concentration of NNC172-2021 (Cmax)

Time point for maximal concentration (tmax)

Terminal half-life (t1/2)

Number of adverse events (AEs)

Presence of antibodies against NNC172-2021

Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation

TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)

Full Information

NCT ID

NCT01555749

First Posted

March 13, 2012

Last Updated

February 23, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01555749

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

March 12, 2012 (Actual)

Primary Completion Date

May 8, 2012 (Actual)

Study Completion Date

May 8, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC172-2021 low dose / Placebo

Arm Type

Experimental

Arm Title

NNC172-2021 high dose / Placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

NNC172-2021

Intervention Description

One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

One injection administered subcutaneously (s.c., under the skin)

Primary Outcome Measure Information:

Title

Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021

Time Frame

Week 5

Secondary Outcome Measure Information:

Title

Maximal concentration of NNC172-2021 (Cmax)

Time Frame

Week 5

Title

Time point for maximal concentration (tmax)

Time Frame

Week 5

Title

Terminal half-life (t1/2)

Time Frame

Week 5

Title

Number of adverse events (AEs)

Time Frame

Week 5

Title

Presence of antibodies against NNC172-2021

Time Frame

Week 5

Title

Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation

Time Frame

Week 5

Title

TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)

Time Frame

Week 5

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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