HealthyPhase 1NCT01499004
A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
A Phase 1 study testing tofacitinib (CP-690,550) modified-release formulation A, tofacitinib (CP-690,550) modified-release formulation B1 and tofacitinib (CP-690,550) modified-release formulation B2 in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tofacitinib (CP-690,550) modified-release formulation A, tofacitinib (CP-690,550) modified-release formulation B1 and tofacitinib (CP-690,550) modified-release formulation B2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2011to Dec 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 subjects and/or healthy females subjects who are of non-childbearing potential.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- Clinically significant infections within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
- Conditions
- Healthy
- Being tested
- tofacitinib (CP-690,550) modified-release formulation A, tofacitinib (CP-690,550) modified-release formulation B1, tofacitinib (CP-690,550) modified-release formulation B2, tofacitinib (CP-690,550) immediate-release formulation
- Keywords
- tofacitinib, CP-690, 550, relative bioavailability, modified release, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tofacitinib (CP-690,550) modified-release formulation ADrug
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
tofacitinib (CP-690,550) modified-release formulation B1Drug
A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
tofacitinib (CP-690,550) modified-release formulation ADrug
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
tofacitinib (CP-690,550) modified-release formulation B1Drug
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
tofacitinib (CP-690,550) modified-release formulation B2Drug
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
tofacitinib (CP-690,550) immediate-release formulationDrug
A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | tofacitinib (CP-690,550) modified-release formulation A-Fed Receives: Drug: tofacitinib (CP-690,550) modified-release formulation A |
| Treatment B | Experimental | tofacitinib (CP-690,550) modified-release formulation B1-Fed Receives: Drug: tofacitinib (CP-690,550) modified-release formulation B1 |
| Treatment C | Experimental | tofacitinib (CP-690,550) modified-release formulation A-Fasted Receives: Drug: tofacitinib (CP-690,550) modified-release formulation A |
| Treatment D | Experimental | tofacitinib (CP-690,550) modified-release formulation B1-Fasted Receives: Drug: tofacitinib (CP-690,550) modified-release formulation B1 |
| Treatment E | Experimental | tofacitinib (CP-690,550) modified-release formulation B2-Fasted Receives: Drug: tofacitinib (CP-690,550) modified-release formulation B2 |
| Treatment F | Experimental | tofacitinib (CP-690,550) immediate-release formulation-Fasted Receives: Drug: tofacitinib (CP-690,550) immediate-release formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
Measured: 72 hours post dose
AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration
Measured: 72 hours post dose
Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)
Measured: 72 hours post dose
Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration
Measured: 72 hours post dose
t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma
Measured: 72 hours post dose
Secondary outcomes (1)
Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499004
- Sponsor's protocol ID
- A3921131
- Status last verified
- Jan 2012
- First submitted
- 23 Nov 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01499004
- Acronym / sponsor ID
- A3921131
- Conditions
- Healthy
- Keywords
- tofacitinib, CP-690, 550, relative bioavailability, modified release, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Dec 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.
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: tofacitinib (CP-690,550) modified-release formulation Atofacitinib (CP-690,550) modified-release formulation A-Fed |
| Treatment B | Experimental | Drug: tofacitinib (CP-690,550) modified-release formulation B1tofacitinib (CP-690,550) modified-release formulation B1-Fed |
| Treatment C | Experimental | Drug: tofacitinib (CP-690,550) modified-release formulation Atofacitinib (CP-690,550) modified-release formulation A-Fasted |
| Treatment D | Experimental | Drug: tofacitinib (CP-690,550) modified-release formulation B1tofacitinib (CP-690,550) modified-release formulation B1-Fasted |
| Treatment E | Experimental | Drug: tofacitinib (CP-690,550) modified-release formulation B2tofacitinib (CP-690,550) modified-release formulation B2-Fasted |
| Treatment F | Experimental | Drug: tofacitinib (CP-690,550) immediate-release formulationtofacitinib (CP-690,550) immediate-release formulation-Fasted |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- Clinically significant infections within the past 3 months
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 |
|---|---|---|
| tofacitinib (CP-690,550) modified-release formulation AA single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food. | Drug | Treatment A |
| tofacitinib (CP-690,550) modified-release formulation B1A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food | Drug | Treatment B |
| tofacitinib (CP-690,550) modified-release formulation AA single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food | Drug | Treatment C |
| tofacitinib (CP-690,550) modified-release formulation B1A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food | Drug | Treatment D |
| tofacitinib (CP-690,550) modified-release formulation B2A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food | Drug | Treatment E |
| tofacitinib (CP-690,550) immediate-release formulationA single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food | Drug | Treatment F |
Primary outcome
AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time
Time frame: 72 hours post dose
AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration
Time frame: 72 hours post dose
Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)
Time frame: 72 hours post dose
Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration
Time frame: 72 hours post dose
t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma
Time frame: 72 hours post dose
1 secondary outcome
Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation
Time frame: 24 hours post dose
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 12 Jan 2012.
- 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 tofacitinib (CP-690,550) modified-release formulation A, tofacitinib (CP-690,550) modified-release formulation B1 and tofacitinib (CP-690,550) modified-release formulation B2 in people with Healthy, 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 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 12 Jan 2012. 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?
AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time (time frame: 72 hours post dose). The study lists 5 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 12 Jan 2012.