Bioavailability Study on Healthy VolunteersPhase 1NCT00813774
Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers
A Phase 1 study testing Certolizumab pegol in people with Bioavailability Study on Healthy Volunteers, run by UCB Pharma at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Study on Healthy Volunteers
- What is being tested?
- Certolizumab pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Being tested
- Certolizumab pegol
- Keywords
- Cimzia, certolizumab pegol, Bioavailability, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolBiological
Also called Cimzia, CDP870
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
Certolizumab pegolBiological
Also called Cimzia, CDP870
Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg
Certolizumab pegolBiological
Also called Cimzia, CDP870
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
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Lyophilized formulation (reference) Receives: Biological: Certolizumab pegol |
| Liquid | Experimental | Liquid Formulation (test) Receives: Biological: Certolizumab pegol |
| Pre-filled Syringe | Experimental | Pre-filled syringe (test) Receives: Biological: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Measured: 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),)
Measured: PK samples: from pre-dose to Week 12
Maximum plasma concentration (Cmax)
Measured: PK samples: from pre-dose to Week 12
Secondary outcomes (9)
Time point where log-linear elimination phase begins (TLIN )
Measured: PK samples: from pre-dose to Week 12
Lowest quantifiable concentration time (LQCT)
Measured: PK samples: from pre-dose to Week 12
Apparent terminal elimination rate constant (λz)
Measured: PK samples: from pre-dose to Week 12
Apparent terminal elimination half-life (t1/2)
Measured: PK samples: from pre-dose to Week 12
Time corresponding to Cmax (tmax)
Measured: PK samples: from pre-dose to Week 12
Apparent Total body clearance (CL/F)
Measured: PK samples: from pre-dose to Week 12
Apparent Volume of distribution (Vz/F)
Measured: PK samples: from pre-dose to Week 12
Extrapolated portion of the AUC (AUC_ext )
Measured: PK samples; from pre-dose to Week 12
Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL
Measured: PK samples; from pre-dose to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability Study on Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813774
- Sponsor's protocol ID
- RA0003
- Other IDs
- Eudract no. 2007-006344-22
- Status last verified
- Sep 2009
- First submitted
- 19 Dec 2008
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00813774
- Acronym / sponsor ID
- RA0003
- Keywords
- Cimzia, certolizumab pegol, Bioavailability, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Biological: Certolizumab pegolLyophilized formulation (reference) |
| Liquid | Experimental | Biological: Certolizumab pegolLiquid Formulation (test) |
| Pre-filled Syringe | Experimental | Biological: Certolizumab pegolPre-filled syringe (test) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab pegolAlso: Cimzia, CDP870Lyophilized 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 | Biological | Reference |
| Certolizumab pegolAlso: Cimzia, CDP870Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg | Biological | Liquid |
| Certolizumab pegolAlso: Cimzia, CDP870200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg | Biological | Pre-filled Syringe |
Primary outcome
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC)
Time frame: 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
Maximum plasma concentration (Cmax)
Time frame: PK samples: from pre-dose to Week 12
9 secondary outcomes
Time point where log-linear elimination phase begins (TLIN )
Time frame: PK samples: from pre-dose to Week 12
Lowest quantifiable concentration time (LQCT)
Time frame: PK samples: from pre-dose to Week 12
Apparent terminal elimination rate constant (λz)
Time frame: 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
Time corresponding to Cmax (tmax)
Time frame: PK samples: from pre-dose to Week 12
Apparent Total body clearance (CL/F)
Time frame: PK samples: from pre-dose to Week 12
Apparent Volume of distribution (Vz/F)
Time frame: 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
Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL
Time frame: PK samples; from pre-dose to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Certolizumab pegol in people with Bioavailability Study on Healthy Volunteers, run by UCB Pharma at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma drug concentration-time curve from time 0 to infinity (AUC) (time frame: PK samples: from pre-dose to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.