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OpenTrials
Completed

NCT Number: NCT00813774

Bio-availability Comparison of Three Formulations of Certolizumab Pegol in 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.

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Key information

Conditions

Bioavailability Study on Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Certolizumab Pegol

Biological

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

Primary outcomes

  1. Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)

    Time frame: PK samples: from pre-dose to Week 12

  2. 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

  3. Maximum plasma concentration (Cmax)

    Time frame: PK samples: from pre-dose to Week 12

Secondary outcomes

  1. Time point where log-linear elimination phase begins (TLIN )

    Time frame: PK samples: from pre-dose to Week 12

  2. Lowest quantifiable concentration time (LQCT)

    Time frame: PK samples: from pre-dose to Week 12

  3. Apparent terminal elimination rate constant (λz)

    Time frame: PK samples: from pre-dose to Week 12

  4. Apparent terminal elimination half-life (t1/2)

    Time frame: PK samples: from pre-dose to Week 12

  5. Time corresponding to Cmax (tmax)

    Time frame: PK samples: from pre-dose to Week 12

  6. Apparent Total body clearance (CL/F)

    Time frame: PK samples: from pre-dose to Week 12

  7. Apparent Volume of distribution (Vz/F)

    Time frame: PK samples: from pre-dose to Week 12

  8. Extrapolated portion of the AUC (AUC_ext )

    Time frame: PK samples; from pre-dose to Week 12

  9. Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL

    Time frame: PK samples; from pre-dose to Week 12

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2008
Registry last updated
Sep 9, 2013

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.