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

• Status: Completed
• Trial end date: 2012-05-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

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)