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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01563471

First received: March 23, 2012

Last updated: June 26, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2012

Last Updated Date

June 26, 2012

Start Date ^ICMJE

October 2001

Primary Completion Date

July 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01563471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean residence time (MRT) [ Designated as safety issue: No ]
Maximum plasma concentration (Cmax) [ Designated as safety issue: No ]
Time to reach maximum plasma concentration (tmax) [ Designated as safety issue: No ]
Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time) [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: activated recombinant human factor VII
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
Drug: placebo
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

Study Arm (s)

Experimental: Treatment sequence 1
Interventions:
- Drug: activated recombinant human factor VII
- Drug: placebo
Experimental: Treatment sequence 2
Interventions:
- Drug: activated recombinant human factor VII
- Drug: placebo
Experimental: Treatment sequence 3
Interventions:
- Drug: activated recombinant human factor VII
- Drug: placebo
Placebo Comparator: Treatment sequence 4
Interventions:
- Drug: activated recombinant human factor VII
- Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2002

Primary Completion Date

July 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01563471

Other Study ID Numbers ^ICMJE

F7LIVER-1465

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Marianne J. Fridberg

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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