NCT00813774

Brief Summary

To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

December 19, 2008

Last Update Submit

September 6, 2013

Conditions

Bioavailability Study on Healthy Volunteers

Keywords

Cimziacertolizumab pegolBioavailabilityHealthy volunteers

Outcome Measures

Primary Outcomes (3)

  • Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)

    PK samples: from pre-dose to Week 12

  • Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)

    PK samples: from pre-dose to Week 12

  • Maximum plasma concentration (Cmax)

    PK samples: from pre-dose to Week 12

Secondary Outcomes (9)

  • Time point where log-linear elimination phase begins (TLIN )

    PK samples: from pre-dose to Week 12

  • Lowest quantifiable concentration time (LQCT)

    PK samples: from pre-dose to Week 12

  • Apparent terminal elimination rate constant (λz)

    PK samples: from pre-dose to Week 12

  • Apparent terminal elimination half-life (t1/2)

    PK samples: from pre-dose to Week 12

  • Time corresponding to Cmax (tmax)

    PK samples: from pre-dose to Week 12

  • +4 more secondary outcomes

Study Arms (3)

Reference

ACTIVE COMPARATOR

Lyophilized formulation (reference)

Biological: Certolizumab pegol

Liquid

EXPERIMENTAL

Liquid Formulation (test)

Biological: Certolizumab pegol

Pre-filled Syringe

EXPERIMENTAL

Pre-filled syringe (test)

Biological: Certolizumab pegol

Interventions

Certolizumab pegolBIOLOGICAL

Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg

Also known as: Cimzia, CDP870
Reference

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers aged between 18 and 55
  • Body Mass Index (BMI) between 18 and 30 kg/m2 with normal laboratory data
  • negative for Tuberculosis test
  • normal Electrocardiogram (ECG)
  • adequate contraception for females
  • given informed consent

You may not qualify if:

  • Any significant abnormality in medical history, physical examination, laboratory testing
  • Intake of concomitant medication
  • smoking more than 10 cigarettes per day
  • alcohol or drug abuse
  • pregnancy or breast feeding
  • history of tuberculosis
  • participation in another trial within 3 months prior to this study
  • previous administration of certolizumab pegol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Rennes, France

Location

Unknown Facility

Rueil-Malmaison, France

Location

MeSH Terms

Interventions

Certolizumab Pegol

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 23, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 9, 2013

Record last verified: 2009-09

Locations

FR(2)