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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555749
• Other study ID #: NN7415-3981
• Secondary ID: 2011-004575-36U1
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2012
• Last updated: February 23, 2017
• Start date: March 12, 2012
• Est. completion date: May 8, 2012

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 8, 2012
• Est. primary completion date: May 8, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Healthy
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• NNC172-2021
One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
• placebo
One injection administered subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve from time point 0 to infinity (AUC0-8) of NNC172-2021		Week 5
Secondary	Maximal concentration of NNC172-2021 (Cmax)		Week 5
Secondary	Time point for maximal concentration (tmax)		Week 5
Secondary	Terminal half-life (t1/2)		Week 5
Secondary	Number of adverse events (AEs)		Week 5
Secondary	Presence of antibodies against NNC172-2021		Week 5
Secondary	Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation		Week 5
Secondary	TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)		Week 5

External Links

•   Clinical Trials at Novo Nordisk