Clinical trial NCT00813774: Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability Study on Healthy Volunteers
Keywords: Cimzia
certolizumab pegol
Bioavailability
Healthy volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
timeFrame: PK samples: from pre-dose to Week 12
measure: Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)
timeFrame: PK samples: from pre-dose to Week 12
measure: Maximum plasma concentration (Cmax)
timeFrame: PK samples: from pre-dose to Week 12
Secondary outcomes:
measure: Time point where log-linear elimination phase begins (TLIN )
timeFrame: PK samples: from pre-dose to Week 12
measure: Lowest quantifiable concentration time (LQCT)
timeFrame: PK samples: from pre-dose to Week 12
measure: Apparent terminal elimination rate constant (λz)
timeFrame: PK samples: from pre-dose to Week 12
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: PK samples: from pre-dose to Week 12
measure: Time corresponding to Cmax (tmax)
timeFrame: PK samples: from pre-dose to Week 12
measure: Apparent Total body clearance (CL/F)
timeFrame: PK samples: from pre-dose to Week 12
measure: Apparent Volume of distribution (Vz/F)
timeFrame: PK samples: from pre-dose to Week 12
measure: Extrapolated portion of the AUC (AUC_ext )
timeFrame: PK samples; from pre-dose to Week 12
measure: Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL
timeFrame: PK samples; from pre-dose to Week 12
Other outcomes:
Locations:
city: Rennes
country: France
city: Rueil Malmaison
country: France
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: