Rheumatoid ArthritisPhase 1NCT00782600
Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers
A Phase 1 study testing suspension IR, CR 1 and CR 2 in people with Rheumatoid Arthritis, run by Pfizer at 1 site in United States.
Trial summary
This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation. 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
- What is being tested?
- suspension IR, CR 1 and CR 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 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/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- condition possibly affecting drug absorption (eg, gastrectomy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers
This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.
- Conditions
- Rheumatoid Arthritis
- Being tested
- suspension IR, CR 1, CR 2, CR 3
- Keywords
- Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspension IRDrug
50 mg IR suspension once daily for one day
CR 1Drug
50 mg shorter release CR once daily for one day
CR 2Drug
50 mg medium release CR once daily for one day
CR 3Drug
longer release SR formulation once daily for one day
| Study group | Role | What they receive |
|---|---|---|
| 50 mg oral suspension | Experimental | once daily for one day Receives: Drug: suspension IR |
| 50 mg CR Type 1 | Experimental | once daily for one day Receives: Drug: CR 1 |
| 50 mg CR Type 2 | Experimental | once daily for one day Receives: Drug: CR 2 |
| 50 mg SR Type 3 | Experimental | once daily for one day Receives: Drug: CR 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.
Measured: 1 month
Secondary outcomes (3)
Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram
Measured: 1 month
Other safety parameters including: physical examination and vital signs.
Measured: 1 month
Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT00782600
- Sponsor's protocol ID
- A6341011
- Status last verified
- Jun 2009
- First submitted
- 27 Oct 2008
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00782600
- Acronym / sponsor ID
- A6341011
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Oct 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.
This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 mg oral suspension | Experimental | Drug: suspension IRonce daily for one day |
| 50 mg CR Type 1 | Experimental | Drug: CR 1once daily for one day |
| 50 mg CR Type 2 | Experimental | Drug: CR 2once daily for one day |
| 50 mg SR Type 3 | Experimental | Drug: CR 3once daily for one day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- condition possibly affecting drug absorption (eg, gastrectomy).
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 |
|---|---|---|
| suspension IR50 mg IR suspension once daily for one day | Drug | 50 mg oral suspension |
| CR 150 mg shorter release CR once daily for one day | Drug | 50 mg CR Type 1 |
| CR 250 mg medium release CR once daily for one day | Drug | 50 mg CR Type 2 |
| CR 3longer release SR formulation once daily for one day | Drug | 50 mg SR Type 3 |
Primary outcome
Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.
Time frame: 1 month
3 secondary outcomes
Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram
Time frame: 1 month
Other safety parameters including: physical examination and vital signs.
Time frame: 1 month
Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.
Time frame: 1 month
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 Jun 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 suspension IR, CR 1 and CR 2 in people with Rheumatoid Arthritis, 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 4 inclusion and 3 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 Jun 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?
Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. (time frame: 1 month). 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 Jun 2009.