Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers

September 6, 2013 updated by: UCB Pharma

Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
      • Rueil Malmaison, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female volunteers aged between 18 and 55
  • Body Mass Index (BMI) between 18 and 30 kg/m2 with normal laboratory data
  • negative for Tuberculosis test
  • normal Electrocardiogram (ECG)
  • adequate contraception for females
  • given informed consent

Exclusion Criteria:

  • Any significant abnormality in medical history, physical examination, laboratory testing
  • Intake of concomitant medication
  • smoking more than 10 cigarettes per day
  • alcohol or drug abuse
  • pregnancy or breast feeding
  • history of tuberculosis
  • participation in another trial within 3 months prior to this study
  • previous administration of certolizumab pegol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Reference
Lyophilized formulation (reference)
Biological: Certolizumab pegol
Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
EXPERIMENTAL: Liquid
Liquid Formulation (test)
Biological: Certolizumab pegol
Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
EXPERIMENTAL: Pre-filled Syringe
Pre-filled syringe (test)
Biological: Certolizumab pegol
Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870
Biological: Certolizumab pegol
200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
Other Names:
  • Cimzia
  • CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Maximum plasma concentration (Cmax)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Time point where log-linear elimination phase begins (TLIN )
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Lowest quantifiable concentration time (LQCT)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Apparent terminal elimination rate constant (λz)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Apparent terminal elimination half-life (t1/2)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Time corresponding to Cmax (tmax)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Apparent Total body clearance (CL/F)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Apparent Volume of distribution (Vz/F)
Time Frame: PK samples: from pre-dose to Week 12
PK samples: from pre-dose to Week 12
Extrapolated portion of the AUC (AUC_ext )
Time Frame: PK samples; from pre-dose to Week 12
PK samples; from pre-dose to Week 12
Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL
Time Frame: PK samples; from pre-dose to Week 12
PK samples; from pre-dose to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (ESTIMATE)

December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0003
  • Eudract no. 2007-006344-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bioavailability Study on Healthy Volunteers

Clinical Trials on Certolizumab pegol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe