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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia B; Haemophilia A; Healthy
• Interventions: Drug: NNC172-2021; Drug: placebo

• Registration Number: NCT01555749
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2012-05-08
• Study Completion: 2012-05-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC172-2021 low dose / Placebo	NNC172-2021	-
NNC172-2021 low dose / Placebo	placebo	-
NNC172-2021 high dose / Placebo	NNC172-2021	-
NNC172-2021 high dose / Placebo	placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Harrow, United Kingdom