Bioavailability Study on Healthy Volunteers
Conditions
Keywords
Cimzia, certolizumab pegol, Bioavailability, Healthy volunteers
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.
Interventions
BIOLOGICALCertolizumab 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
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity (AUC) | 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),) | PK samples: from pre-dose to Week 12 |
| Maximum plasma concentration (Cmax) | PK samples: from pre-dose to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Apparent terminal elimination half-life (t1/2) | PK samples: from pre-dose to Week 12 |
| Time corresponding to Cmax (tmax) | PK samples: from pre-dose to Week 12 |
| Apparent Total body clearance (CL/F) | PK samples: from pre-dose to Week 12 |
| Time point where log-linear elimination phase begins (TLIN ) | PK samples: from pre-dose to Week 12 |
| Extrapolated portion of the AUC (AUC_ext ) | PK samples; from pre-dose to Week 12 |
| Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL | PK samples; from pre-dose to Week 12 |
| Apparent Volume of distribution (Vz/F) | PK samples: from pre-dose to Week 12 |
| Lowest quantifiable concentration time (LQCT) | PK samples: from pre-dose to Week 12 |
| Apparent terminal elimination rate constant (λz) | PK samples: from pre-dose to Week 12 |
Countries
France
Outcome results
None listed