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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563471

F7LIVER-1465

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 4 patient groups, including a placebo group

Treatment sequence 1

Experimental group

Treatment:

Drug: placebo

Drug: activated recombinant human factor VII

Treatment sequence 2

Experimental group

Treatment:

Drug: placebo

Drug: activated recombinant human factor VII

Treatment sequence 3

Experimental group

Treatment:

Drug: placebo

Drug: activated recombinant human factor VII

Treatment sequence 4

Placebo Comparator group

Treatment:

Drug: placebo

Drug: activated recombinant human factor VII