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COMPLETEDPhase 1NCT01563471

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...

Lead sponsor: Novo Nordisk A/S•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novo Nordisk A/S

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 13, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment39

Start dateOct 2001

Last updatedJan 13, 2017

Condition

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

Locations shown

Novo Nordisk Investigational Site

Paris

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2017Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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