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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-12

Study Completion Date

2012-05-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC172-2021 low dose / Placebo

Group Type EXPERIMENTAL

NNC172-2021

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

NNC172-2021 high dose / Placebo

Group Type EXPERIMENTAL

NNC172-2021

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Interventions

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NNC172-2021

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes