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

NCT00951873 | Completed Phase 1

• 2 other identifiers: NN7129-37542009-011267-37
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  assessed throughout the trial period from visit 1 to visit 5

Secondary Outcomes (1)

• Area under activity concentration-time curve from time zero to infinity

  assessed up to 168 hours after trial product administration

Study Arms (3)

A

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

B

PLACEBO COMPARATOR

Drug: placebo

C

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

Interventions

activated recombinant human factor VII, long acting DRUG

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.

A

placebo DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

GB (1)