Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00845663
First received: February 13, 2009
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: Certolizumab pegol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t)) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time Point Where Log-linear Elimination Phase Begins (TLIN) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
    TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.

  • Lowest Quantifiable Concentration Time (LQCT) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Apparent Terminal Elimination Rate Constant (λz) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Apparent Terminal Elimination Half-life (t1/2) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Time Corresponding to Cmax (Tmax) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Apparent Total Body Clearance (CL/F) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL [ Time Frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Immediately after injection and 1 hour after injection ] [ Designated as safety issue: Yes ]
    Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).

  • Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles [ Time Frame: Before and 24 hours post-dose ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections [ Time Frame: Before and 24 hours post-dose ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain [ Time Frame: Immediately after injection, 1 h and 24 h after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.

  • Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening [ Time Frame: Immediately after injection, 1 hour and 24 hours after injection ] [ Designated as safety issue: Yes ]
    Categorized answer ranges from not at all to extremely.


Enrollment: 98
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pre-filled Syringe
pre-filled syringe (reference)
Drug: Certolizumab pegol
Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Other Names:
  • Cimzia®
  • CDP870
  • CZP
Experimental: Auto-injection Device
Auto-injection device (test)
Drug: Certolizumab pegol
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Other Names:
  • Cimzia®
  • CDP870
  • CZP

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845663

Locations
France
Rennes, France
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00845663     History of Changes
Other Study ID Numbers: C87045
Study First Received: February 13, 2009
Results First Received: August 25, 2009
Last Updated: August 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
certolizumab pegol
Cimzia
bioequivalence
Comparison Bioequivalence Study

Additional relevant MeSH terms:
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014