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Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00813774
First received: December 19, 2008
Last updated: May 25, 2012
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Bioavailability Study on Healthy Volunteers
 Biological: Certolizumab pegol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Area under the plasma drug concentration-time curve from time 0 to infinity (AUC) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time point where log-linear elimination phase begins (TLIN ) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Lowest quantifiable concentration time (LQCT) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Apparent terminal elimination rate constant (λz) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Apparent terminal elimination half-life (t1/2) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Time corresponding to Cmax (tmax) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Apparent Total body clearance (CL/F) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Apparent Volume of distribution (Vz/F) [ Time Frame: PK samples: from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Extrapolated portion of the AUC (AUC_ext ) [ Time Frame: PK samples; from pre-dose to Week 12 ] [ Designated as safety issue: No ]
  • Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL [ Time Frame: PK samples; from pre-dose to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference
Lyophilized formulation (reference)
 Biological: Certolizumab pegol
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
Other Names:
  • Cimzia
  • CDP870
Experimental: Liquid
Liquid Formulation (test)
 Biological: Certolizumab pegol
Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Experimental: Pre-filled Syringe
Pre-filled syringe (test)
 Biological: Certolizumab pegol
200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813774

Locations
France
Rennes, France
Rueil Malmaison, France
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00813774     History of Changes
Other Study ID Numbers: RA0003, Eudract no. 2007-006344-22
Study First Received: December 19, 2008
Last Updated: May 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
Cimzia
certolizumab pegol
Bioavailability
Healthy volunteers

Additional relevant MeSH terms:
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013