NCT00813774CompletedPhase 1
Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 149
- Locations
- 2
- Primary Endpoint
- Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pre-filled Syringe
Experimental
Pre-filled syringe (test)
Intervention: Certolizumab pegol (Biological)
Liquid
Experimental
Liquid Formulation (test)
Intervention: Certolizumab pegol (Biological)
Reference
Active Comparator
Lyophilized formulation (reference)
Intervention: Certolizumab pegol (Biological)
Outcomes
Primary Outcomes
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
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Time Frame: PK samples: from pre-dose to Week 12
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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