Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272206
First received: January 6, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Drug: NNC 0128-0000-2011
Drug: NNC 0128-0000-2021
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of adverse events (AEs) [ Time Frame: from first trial product administration until maximally 10 weeks after last trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neutralising antibodies against FVII and/or N7-GP [ Time Frame: from first trial product administration until maximally 10 weeks after last trial product administration ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NNC 0128-0000-2011
Administered as one single i.v. (intravenous) injection, 100 mcg/kg
Experimental: B Drug: NNC 0128-0000-2021
Administered as one single i.v. (intravenous) injection, 100 mcg/kg

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight between 50.0 and 100.0 kg, both inclusive
  • Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
  • Any clinical sign or known history of atherosclerosis or thromboembolic events
  • Renal dysfunction
  • A subject considered at high risk of thromboembolic events
  • Overt bleeding, including from gastrointestinal tract
  • Hepatitis B or C infection
  • Human immunodeficiency virus (HIV) infection
  • Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
  • Smoking within 3 months prior to trial start
  • Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
  • Excessive consumption of a diet deviating from a normal diet
  • Blood donation within the last three months prior to screening
  • The receipt of any investigational product within 30 days of trial product administration
  • Participation in any other trial investigating a procoagulant within the last six months prior to screening
  • Strenuous exercise within four days prior trial start
  • Suffers from a life threatening disease
  • Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
  • Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
  • Subjects with high fasting cholesterol at trial start
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272206

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272206     History of Changes
Other Study ID Numbers: NN7128-3729, 2010-021286-67, U1111-1118-0208
Study First Received: January 6, 2011
Last Updated: August 19, 2014
Health Authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemophilia B
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014