Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

January 10, 2017 updated by: Novo Nordisk A/S

A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Berkshire, United Kingdom, SL1 2 AD
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal platelet count and clotting parameters
  • Adequate renal and hepatic function
  • If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
  • If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
  • Negative drug and alcohol screens

Exclusion Criteria:

  • Known antibodies or hypersensitivity to FXIII
  • Known bleeding or hematologic disorder
  • Known allergy to yeast
  • Receipt of blood products within 30 days of screening
  • Donation of blood within 30 days prior to enrollment
  • Any surgical procedure in the 30 days prior to enrollment
  • Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
  • Receipt of treatment with any experimental agent within 30 days of study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
Experimental: rFXIII
Drug: catridecacog
Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Days 0-28
Days 0-28

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements
Time Frame: Days 0-28
Days 0-28
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)
Time Frame: Days 0-28
Days 0-28
Incidence of yeast antibodies
Time Frame: Days 0-28
Days 0-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F13-1661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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