Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Healthy; Haemophilia B With Inhibitors
• Interventions: Drug: activated recombinant human factor VII; Drug: placebo

• Registration Number: NCT01563471
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Caucasian or Japanese
• Healthy as defined by medical history, physical and biological examinations

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Exclusion Criteria

• History of allergy or hypersensitivity reaction to any medication
• History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
• Alcohol or substance abuse disorder
• Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1	activated recombinant human factor VII	-
Treatment sequence 1	placebo	-
Treatment sequence 2	activated recombinant human factor VII	-
Treatment sequence 2	placebo	-
Treatment sequence 3	activated recombinant human factor VII	-
Treatment sequence 3	placebo	-
Treatment sequence 4	activated recombinant human factor VII	-
Treatment sequence 4	placebo	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum plasma concentration (tmax)
Mean residence time (MRT)
Maximum plasma concentration (Cmax)
Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris, France