Clinical trial NCT01555749: Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
timeFrame: Week 5
Secondary outcomes:
measure: Maximal concentration of NNC172-2021 (Cmax)
timeFrame: Week 5
measure: Time point for maximal concentration (tmax)
timeFrame: Week 5
measure: Terminal half-life (t1/2)
timeFrame: Week 5
measure: Number of adverse events (AEs)
timeFrame: Week 5
measure: Presence of antibodies against NNC172-2021
timeFrame: Week 5
measure: Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation
timeFrame: Week 5
measure: TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)
timeFrame: Week 5
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: