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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00813774

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Parallel Assignment, Bio-availability Study
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:

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB:

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
Reference: Active Comparator 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
Liquid: Experimental 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
Pre-filled Syringe: Experimental 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

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

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	RA0003, Eudract no. 2007-006344-22
Study First Received:	December 19, 2008
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00813774 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

Cimzia
certolizumab pegol
Bioavailability
Healthy volunteers

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Immunologic Factors
Healthy
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2009