Rheumatoid ArthritisPhase 1NCT00838058
A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
A Phase 1 study testing CE-224,535 and CE 224,535 in people with Rheumatoid Arthritis and Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Healthy Volunteers
- What is being tested?
- CE-224,535 and CE 224,535
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2009
- 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
- aged 18-55 and healthy
Who cannot join
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers
- Being tested
- CE-224,535, CE 224,535
- Keywords
- pharmacology formulation normal healthy volunteers food effect
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-224,535Drug
Also called Part 1;Treatment A
one 250mg tablet, once in the morning in fasted state
CE-224,535Drug
Also called Part 1;Treatment B
2x250 mg tablets, once in the morning, in fasted state
CE-224,535Drug
Also called Part 1;Treatment C
4x250mg tablets, once in the morning, in fasted state
CE-224,535Drug
Also called Part 1;Treatment D
2x250mg tab, once in the morning, after being fed a high fat meal
CE-224,535Drug
Also called Part 2;Treatment E
4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.
CE-224,535Drug
Also called Part 2; Treatment F
4x125 mg IR once in the morning after being fed a high fat meal
CE 224,535Drug
Also called Part 2; Treatment G
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
CE 224,535Drug
Also called Part 2; Treatment H
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
| Study group | Role | What they receive |
|---|---|---|
| Part1; controlled release formulation 4; 250 mg | Experimental | one 250 mg controlled release tablet, once in the morning, in fasted state Receives: Drug: CE-224,535 |
| Part1; controlled release formulation 4; 500 mg | Experimental | 2x250 mg, once in the morning, in fasted state Receives: Drug: CE-224,535 |
| Part 1; controlled release formula 4; 1000 mg | Experimental | 4x250 mg tabs, once in the morning, in fasted state Receives: Drug: CE-224,535 |
| Part 1; controlled release formulation 4; 500 mg FED | Experimental | 2x250 mg, once in the morning , in fed state Receives: Drug: CE-224,535 |
| Part 2; IR formulation 500mg | Experimental | 4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1 Receives: Drug: CE-224,535 |
| Part 2; IR formulation, 500 mg FED | Experimental | 4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1. Receives: Drug: CE-224,535 |
| Part 2; controlled release formulation 5;500 mg, FASTED | Experimental | 2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1. Receives: Drug: CE 224,535 |
| Part 2; controlled release formulation 5;500 mg, FED | Experimental | 2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1 Receives: Drug: CE 224,535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Measured: 48 hrs
Secondary outcomes (1)
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838058
- Sponsor's protocol ID
- A6341012
- Status last verified
- Oct 2009
- First submitted
- 2 Feb 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00838058
- Acronym / sponsor ID
- A6341012
- Conditions
- Rheumatoid Arthritis, Healthy Volunteers
- Keywords
- pharmacology formulation normal healthy volunteers food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Feb 2009 (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.
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part1; controlled release formulation 4; 250 mg | Experimental | Drug: CE-224,535one 250 mg controlled release tablet, once in the morning, in fasted state |
| Part1; controlled release formulation 4; 500 mg | Experimental | Drug: CE-224,5352x250 mg, once in the morning, in fasted state |
| Part 1; controlled release formula 4; 1000 mg | Experimental | Drug: CE-224,5354x250 mg tabs, once in the morning, in fasted state |
| Part 1; controlled release formulation 4; 500 mg FED | Experimental | Drug: CE-224,5352x250 mg, once in the morning , in fed state |
| Part 2; IR formulation 500mg | Experimental | Drug: CE-224,5354x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1 |
| Part 2; IR formulation, 500 mg FED | Experimental | Drug: CE-224,5354x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1. |
| Part 2; controlled release formulation 5;500 mg, FASTED | Experimental | Drug: CE 224,5352x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1. |
| Part 2; controlled release formulation 5;500 mg, FED | Experimental | Drug: CE 224,5352x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged 18-55 and healthy
Key exclusion criteria (2 listed)
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
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 |
|---|---|---|
| CE-224,535Also: Part 1;Treatment Aone 250mg tablet, once in the morning in fasted state | Drug | Part1; controlled release formulation 4; 250 mg |
| CE-224,535Also: Part 1;Treatment B2x250 mg tablets, once in the morning, in fasted state | Drug | Part1; controlled release formulation 4; 500 mg |
| CE-224,535Also: Part 1;Treatment C4x250mg tablets, once in the morning, in fasted state | Drug | Part 1; controlled release formula 4; 1000 mg |
| CE-224,535Also: Part 1;Treatment D2x250mg tab, once in the morning, after being fed a high fat meal | Drug | Part 1; controlled release formulation 4; 500 mg FED |
| CE-224,535Also: Part 2;Treatment E4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1. | Drug | Part 2; IR formulation 500mg |
| CE-224,535Also: Part 2; Treatment F4x125 mg IR once in the morning after being fed a high fat meal | Drug | Part 2; IR formulation, 500 mg FED |
| CE 224,535Also: Part 2; Treatment G2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state | Drug | Part 2; controlled release formulation 5;500 mg, FASTED |
| CE 224,535Also: Part 2; Treatment H2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal | Drug | Part 2; controlled release formulation 5;500 mg, FED |
Primary outcome
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Time frame: 48 hrs
1 secondary outcome
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Time frame: 48 hrs
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 14 Oct 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CE-224,535 and CE 224,535 in people with Rheumatoid Arthritis and Healthy Volunteers, run by Pfizer at 1 site in United States.
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 1 inclusion and 2 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 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 (time frame: 48 hrs). 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 14 Oct 2009.