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

Study Overview
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Brief Summary
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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.

Official Title
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Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

Conditions
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Bioavailability Study on Healthy Volunteers

Intervention / Treatment
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* Biological: Certolizumab pegol
* Biological: Certolizumab pegol
* Biological: Certolizumab pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference<br>Lyophilized formulation (reference) | Biological: Certolizumab pegol<br>* 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<br>* Other names: CDP870;|
| Experimental: Liquid<br>Liquid Formulation (test) | Biological: Certolizumab pegol<br>* Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg<br>* Other names: CDP870;|
| Experimental: Pre-filled Syringe<br>Pre-filled syringe (test) | Biological: Certolizumab pegol<br>* 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<br>* Other names: CDP870;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cimzia, certolizumab pegol, Bioavailability, Healthy volunteers