Rheumatoid ArthritisPhase 1NCT01184092
A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Rheumatoid Arthritis, run by Pfizer at 1 site in Singapore.
Trial summary
In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2010to Sep 2010
- 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 for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Who cannot join
- 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, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions
In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.
Read the detailed description
This is a pivotal bioequivalence study for tasocitinib (CP-690,550).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Treatment A, Treatment B, Treatment C
- 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 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment ADrug
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment ADrug
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment ADrug
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment ADrug
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment CDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Treatment BDrug
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Treatment ADrug
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Sequence 2 | Experimental | Not described Receives: Drug: Treatment A; Drug: Treatment C; Drug: Treatment B |
| Sequence 3 | Experimental | Not described Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment A |
| Sequence 4 | Experimental | Not described Receives: Drug: Treatment B; Drug: Treatment A; Drug: Treatment C |
| Sequence 5 | Experimental | Not described Receives: Drug: Treatment C; Drug: Treatment A; Drug: Treatment B |
| Sequence 6 | Experimental | Not described Receives: Drug: Treatment C; 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 tasocitinib (CP-690,550).
Measured: PK blood samples out to 24 hours post dose in each period
Secondary outcomes (4)
PK parameters: Tmax, t½ of tasocitinib (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 Period 3.
Safety: vital signs
Measured: Prior to dosing in each period and at 24 hours post last dose in Period 3.
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 posted18 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- 24 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
- NCT01184092
- Sponsor's protocol ID
- A3921075
- Status last verified
- Oct 2010
- First submitted
- 16 Aug 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT01184092
- Acronym / sponsor ID
- A3921075
- Conditions
- Rheumatoid Arthritis
- Keywords
- Bioequivalence, healthy volunteer study, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Aug 2010 (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 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.
Detailed description
This is a pivotal bioequivalence study for tasocitinib (CP-690,550).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment C |
| Sequence 2 | Experimental | Drug: Treatment A, Drug: Treatment C, Drug: Treatment B |
| Sequence 3 | Experimental | Drug: Treatment B, Drug: Treatment C, Drug: Treatment A |
| Sequence 4 | Experimental | Drug: Treatment B, Drug: Treatment A, Drug: Treatment C |
| Sequence 5 | Experimental | Drug: Treatment C, Drug: Treatment A, Drug: Treatment B |
| Sequence 6 | Experimental | Drug: Treatment C, 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 for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Key exclusion criteria (3 listed)
- 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 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 1 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 1 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 1 |
| Treatment ASingle oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 2 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 2 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 2 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 3 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 3 |
| Treatment ASingle oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 3 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 4 |
| Treatment ASingle oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 4 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 4 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 5 |
| Treatment ASingle oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 5 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 5 |
| Treatment CSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets). | Drug | Sequence 6 |
| Treatment BSingle oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets). | Drug | Sequence 6 |
| Treatment ASingle oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet). | Drug | Sequence 6 |
Primary outcome
PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).
Time frame: PK blood samples out to 24 hours post dose in each period
4 secondary outcomes
PK parameters: Tmax, t½ of tasocitinib (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 Period 3.
Safety: vital signs
Time frame: Prior to dosing in each period and at 24 hours post last dose in Period 3.
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 14 Oct 2010.
- 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, Treatment B and Treatment C in people with Rheumatoid Arthritis, 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 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 14 Oct 2010. 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 tasocitinib (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 14 Oct 2010.