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A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00951873
First received: July 31, 2009
Last updated: July 4, 2012
Last verified: January 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Healthy
 Drug: activated recombinant human factor VII, long acting
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: assessed throughout the trial period from visit 1 to visit 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under activity concentration-time curve from time zero to infinity [ Time Frame: assessed up to 168 hours after trial product administration ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: activated recombinant human factor VII, long acting
Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Placebo Comparator: B Drug: placebo
Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Experimental: C Drug: activated recombinant human factor VII, long acting
Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian origin
  • Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
  • Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
  • Previous participation in this trial, defined as randomised to receive trial product
  • Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
  • Known history of atherosclerosis or thromboembolic events
  • Overt bleeding, including from gastrointestinal tract
  • Hepatitis B or C infection
  • HIV infection
  • Positive test for drugs of abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951873

Locations
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Camilla Buöen Stenmo, MSc Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00951873     History of Changes
Other Study ID Numbers: NN7129-3754, 2009-011267-37
Study First Received: July 31, 2009
Last Updated: July 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 22, 2013