NCT00845663

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2007

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 17, 2009

Completed
Last Updated

August 31, 2011

Status Verified

December 1, 2009

Enrollment Period

6 months

First QC Date

February 13, 2009

Results QC Date

August 25, 2009

Last Update Submit

August 30, 2011

Conditions

Healthy

Keywords

certolizumab pegolCimziabioequivalenceComparison Bioequivalence Study

Outcome Measures

Primary Outcomes (3)

  • Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Maximum Plasma Concentration (Cmax)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

Secondary Outcomes (19)

  • Time Point Where Log-linear Elimination Phase Begins (TLIN)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Lowest Quantifiable Concentration Time (LQCT)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Apparent Terminal Elimination Rate Constant (λz)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Apparent Terminal Elimination Half-life (t1/2)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • Time Corresponding to Cmax (Tmax)

    After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

  • +14 more secondary outcomes

Study Arms (2)

Pre-filled Syringe

ACTIVE COMPARATOR

pre-filled syringe (reference)

Drug: Certolizumab pegol

Auto-injection Device

EXPERIMENTAL

Auto-injection device (test)

Drug: Certolizumab pegol

Interventions

Certolizumab pegolDRUG

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

Also known as: Cimzia®, CDP870, CZP
Auto-injection Device

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rennes, France

Location

Related Links

MeSH Terms

Interventions

Certolizumab Pegol

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB Pharma
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 18, 2009

Study Start

October 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 31, 2011

Results First Posted

November 17, 2009

Record last verified: 2009-12

Locations

FR(1)