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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy
Haemophilia B
Haemophilia A
Congenital Bleeding Disorder

Treatments

Drug: NNC172-2021
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01555749
U1111-1124-5137 (Other Identifier)
2011-004575-36 (EudraCT Number)
NN7415-3981

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

20 to 64 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

8 participants in 2 patient groups

NNC172-2021 low dose / Placebo
Experimental group
Treatment:
Drug: placebo
Drug: NNC172-2021
NNC172-2021 high dose / Placebo
Experimental group
Treatment:
Drug: placebo
Drug: NNC172-2021

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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