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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00951873
Other study ID # NN7129-3754
Secondary ID 2009-011267-37
Status Completed
Phase Phase 1
First received July 31, 2009
Last updated May 12, 2016
Start date July 2009
Est. completion date April 2010

Study information

Verified date May 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

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
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.
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events assessed throughout the trial period from visit 1 to visit 5 Yes
Secondary Area under activity concentration-time curve from time zero to infinity assessed up to 168 hours after trial product administration No
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