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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy
• Interventions: Drug: placebo; Drug: activated recombinant human factor VII, long acting

• Registration Number: NCT00951873
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-07-31
• Study First Posted: 2009-08-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	-
A	activated recombinant human factor VII, long acting	-
C	activated recombinant human factor VII, long acting	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	assessed throughout the trial period from visit 1 to visit 5

Secondary Outcome Measures

Name	Time	Method
Area under activity concentration-time curve from time zero to infinity	assessed up to 168 hours after trial product administration