Clinical trial NCT00845663: Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Official title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: certolizumab pegol
Cimzia
bioequivalence
Comparison Bioequivalence Study
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).


Eligibility criteria: Inclusion Criteria:

* Age: 18-55 years.
* A Body mass Index (BMI) of 18 to 28 kg/m
* Good physical and mental health status determined on the basis of the medical history and a general clinical examination
* Electrocardiogram and clinical laboratory tests interpreted as "normal"
* QuantiFERON-TB test negative
* female subjects: medically accepted method of contraception

Exclusion Criteria:

* prohibited concomitant medication
* administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
* history of significant disease, allergies
* history of drug and/or alcohol abuse
* hepatic enzyme inducing drug within 2 months before study drug administration
* any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
* known to be intolerant to PEG
* previously received certolizumab pegol
* previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
* history of tuberculosis
* have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive

Primary outcomes:
measure: Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Maximum Plasma Concentration (Cmax)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Secondary outcomes:
measure: Time Point Where Log-linear Elimination Phase Begins (TLIN)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Lowest Quantifiable Concentration Time (LQCT)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Apparent Terminal Elimination Rate Constant (λz)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Apparent Terminal Elimination Half-life (t1/2)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Time Corresponding to Cmax (Tmax)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Apparent Total Body Clearance (CL/F)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL
timeFrame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
measure: Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection
timeFrame: Immediately after injection and 1 hour after injection
measure: Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
timeFrame: Before and 24 hours post-dose
measure: Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
timeFrame: Before and 24 hours post-dose
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
timeFrame: Immediately after injection, 1 h and 24 h after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
measure: Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
timeFrame: Immediately after injection, 1 hour and 24 hours after injection
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: