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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
History of Changes
  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:

U.S. FDA Resources

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
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:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
Product Information  This link exits the ClinicalTrials.gov site

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 May 21, 2013