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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Haemophilia B

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: placebo

Drug: activated recombinant human factor VII, long acting

Study type

Interventional

Funder types

Industry

Identifiers

NCT00951873

NN7129-3754

2009-011267-37 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

38 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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