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: September 6, 2013
Last verified: September 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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: September 6, 2013
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:
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014