Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers
Phase 1
Completed
- Conditions
- Bioavailability Study on Healthy Volunteers
- Interventions
- Biological: Certolizumab pegol
- Registration Number
- NCT00813774
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference Certolizumab pegol Lyophilized formulation (reference) Liquid Certolizumab pegol Liquid Formulation (test) Pre-filled Syringe Certolizumab pegol Pre-filled syringe (test)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Apparent terminal elimination rate constant (λz) PK samples: from pre-dose to Week 12 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 Apparent Volume of distribution (Vz/F) 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 Time point where log-linear elimination phase begins (TLIN ) PK samples: from pre-dose to Week 12 Lowest quantifiable concentration time (LQCT) PK samples: from pre-dose to Week 12 Extrapolated portion of the AUC (AUC_ext ) PK samples; from pre-dose to Week 12