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

NCT01555749 | Completed Phase 1

• 3 other identifiers: NN7415-39812011-004575-36U1111-1124-5137
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021

  Week 5

Secondary Outcomes (7)

• Maximal concentration of NNC172-2021 (Cmax)

  Week 5

• Time point for maximal concentration (tmax)

  Week 5

• Terminal half-life (t1/2)

  Week 5

• Number of adverse events (AEs)

  Week 5

• Presence of antibodies against NNC172-2021

  Week 5

Study Arms (2)

NNC172-2021 low dose / Placebo

EXPERIMENTAL

Drug: NNC172-2021; Drug: placebo

NNC172-2021 high dose / Placebo

EXPERIMENTAL

Drug: NNC172-2021; Drug: placebo

Interventions

NNC172-2021 DRUG

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

NNC172-2021 high dose / Placebo; NNC172-2021 low dose / Placebo

placebo DRUG

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

NNC172-2021 high dose / Placebo; NNC172-2021 low dose / Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Harrow, HA1 3UJ, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: March 12, 2012
• Primary Completion: May 8, 2012
• Study Completion: May 8, 2012
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

GB (1)