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Completed

NCT Number: NCT01563471

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Paris, 75015, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

Placebo

Drug

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

Primary outcomes

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

Secondary outcomes

  1. Mean residence time (MRT)

  2. Maximum plasma concentration (Cmax)

  3. Time to reach maximum plasma concentration (tmax)

  4. Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Mar 27, 2012
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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