Arthritis, RheumatoidPhase 1NCT01277991
A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550
A Phase 1 study testing Treatment A and Treatment B in people with Arthritis, Rheumatoid, run by Pfizer at 1 site in Singapore.
Trial summary
In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Treatment A and Treatment B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2011to Mar 2011
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Who cannot join
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.
- Evidence or history of any clinically significant infections within the past 3 months.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions
In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .
Read the detailed description
This is a bioequivalence study for CP-690,550.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Treatment A, Treatment B
- Keywords
- Bioequivalence, healthy volunteer study, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
Treatment BDrug
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Treatment BDrug
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Treatment ADrug
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: Treatment A; Drug: Treatment B |
| Sequence 2 | Experimental | Not described Receives: Drug: Treatment B; Drug: Treatment A |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters: AUCinf, AUClast and Cmax of CP-690,550
Measured: PK blood samples out to 24 hours post dose in each period
Secondary outcomes (4)
PK parameters: Tmax, AUCt and half-life of CP-690,550
Measured: Derived from PK blood samples out to 24 hours post dose in each period
Safety: laboratory tests
Measured: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
Safety: vital signs
Measured: Prior to dosing in each period and at 24 hours post last dose in Period 2
Safety: adverse event reporting
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- 30 participants (estimated)
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
- NCT01277991
- Sponsor's protocol ID
- A3921135
- Status last verified
- Apr 2011
- First submitted
- 13 Jan 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT01277991
- Acronym / sponsor ID
- A3921135
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Bioequivalence, healthy volunteer study, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Jan 2011 (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.
In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .
Detailed description
This is a bioequivalence study for CP-690,550.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A, Drug: Treatment B |
| Sequence 2 | Experimental | Drug: Treatment B, Drug: Treatment A |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Key exclusion criteria (4 listed)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.
- Evidence or history of any clinically significant infections within the past 3 months.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
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 |
|---|---|---|
| Treatment ASingle oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets) | Drug | Sequence 1 |
| Treatment BSingle oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet) | Drug | Sequence 1 |
| Treatment BSingle oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet) | Drug | Sequence 2 |
| Treatment ASingle oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets) | Drug | Sequence 2 |
Primary outcome
PK parameters: AUCinf, AUClast and Cmax of CP-690,550
Time frame: PK blood samples out to 24 hours post dose in each period
4 secondary outcomes
PK parameters: Tmax, AUCt and half-life of CP-690,550
Time frame: Derived from PK blood samples out to 24 hours post dose in each period
Safety: laboratory tests
Time frame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
Safety: vital signs
Time frame: Prior to dosing in each period and at 24 hours post last dose in Period 2
Safety: adverse event reporting
Time frame: Throughout study
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 7 Apr 2011.
- 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 Treatment A and Treatment B in people with Arthritis, Rheumatoid, run by Pfizer at 1 site in Singapore.
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 3 inclusion and 4 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 7 Apr 2011. 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 Singapore. 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?
PK parameters: AUCinf, AUClast and Cmax of CP-690,550 (time frame: PK blood samples out to 24 hours post dose in each period). 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 7 Apr 2011.