Skip to main content
OpenTrials
Completed

NCT Number: NCT00845663

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol

Drug

Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections

Other names: Cimzia®, CDP870, CZP

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

    Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).

  10. Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles

    Time frame: Before and 24 hours post-dose

    Categorized answer ranges from not at all to extremely.

  11. Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections

    Time frame: Before and 24 hours post-dose

    Categorized answer ranges from not at all to extremely.

  12. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain

    Time frame: Immediately after injection, 1 h and 24 h after injection

    Categorized answer ranges from not at all to extremely.

  13. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  14. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  15. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  16. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  17. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  18. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

  19. Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening

    Time frame: Immediately after injection, 1 hour and 24 hours after injection

    Categorized answer ranges from not at all to extremely.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2009
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.