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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 Pharma
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
Intervention Model: Parallel Assignment
Masking: None (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 Pharma:

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 ]
  • 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 ]
  • Maximum plasma concentration (Cmax) [ Time Frame: PK samples: from pre-dose to Week 12 ]

Secondary Outcome Measures:
  • Time point where log-linear elimination phase begins (TLIN ) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Lowest quantifiable concentration time (LQCT) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Apparent terminal elimination rate constant (λz) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Apparent terminal elimination half-life (t1/2) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Time corresponding to Cmax (tmax) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Apparent Total body clearance (CL/F) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Apparent Volume of distribution (Vz/F) [ Time Frame: PK samples: from pre-dose to Week 12 ]
  • Extrapolated portion of the AUC (AUC_ext ) [ Time Frame: PK samples; from pre-dose to Week 12 ]
  • Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL [ Time Frame: PK samples; from pre-dose to Week 12 ]

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   (Adult)
Sexes Eligible for Study:   All
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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma
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

Keywords provided by UCB Pharma:
Cimzia
certolizumab pegol
Bioavailability
Healthy volunteers

Additional relevant MeSH terms:
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2017