HealthyPhase 1NCT02487433
A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers
A Phase 1 study testing Tofacitinib MR 22 mg (Fed) and Tofacitinib MR 22 mg (Fasted) in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tofacitinib MR 22 mg (Fed) and Tofacitinib MR 22 mg (Fasted)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2015to Jul 2015
- 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 volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
- Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.
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, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers
This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
- Conditions
- Healthy
- Being tested
- Tofacitinib MR 22 mg (Fed), Tofacitinib MR 22 mg (Fasted)
- Keywords
- food effect, pharmacokinetics, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib MR 22 mg (Fed)Drug
A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
Tofacitinib MR 22 mg (Fasted)Drug
A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib MR 22 mg Fed | Experimental | Single dose of tofacitinib MR 22 mg administered under fed conditions Receives: Drug: Tofacitinib MR 22 mg (Fed) |
| Tofacitinib MR 22 mg Fasted | Experimental | Single dose of tofacitinib MR 22 mg administered under fasted conditions Receives: Drug: Tofacitinib MR 22 mg (Fasted) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC inf
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
Measured: 48 hours post dose
AUC last
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Measured: 48 hours post dose
Cmax
Maximum observed plasma concentration (Cmax).
Measured: 48 hours post dose
Secondary outcomes (2)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 48 hours post dose
Plasma Decay Half-Life (t 1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 48 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 posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
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
- 18 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
- NCT02487433
- Sponsor's protocol ID
- A3921217
- Other IDs
- 2014-005056-26, 2014
- Status last verified
- Aug 2015
- First submitted
- 23 Apr 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open Label, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02487433
- Acronym / sponsor ID
- A3921217
- Conditions
- Healthy
- Keywords
- food effect, pharmacokinetics, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Jul 2015 (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 evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib MR 22 mg Fed | Experimental | Drug: Tofacitinib MR 22 mg (Fed)Single dose of tofacitinib MR 22 mg administered under fed conditions |
| Tofacitinib MR 22 mg Fasted | Experimental | Drug: Tofacitinib MR 22 mg (Fasted)Single dose of tofacitinib MR 22 mg administered under fasted conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
- Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.
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 MR 22 mg (Fed)A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal | Drug | Tofacitinib MR 22 mg Fed |
| Tofacitinib MR 22 mg (Fasted)A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours | Drug | Tofacitinib MR 22 mg Fasted |
Primary outcome
AUC inf
Time frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
AUC last
Time frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Cmax
Time frame: 48 hours post dose
Maximum observed plasma concentration (Cmax).
2 secondary outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 48 hours post dose
Plasma Decay Half-Life (t 1/2)
Time frame: 48 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 19 Aug 2015.
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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 MR 22 mg (Fed) and Tofacitinib MR 22 mg (Fasted) in people with Healthy, run by Pfizer at 1 site in Belgium.
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 2 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 19 Aug 2015. 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 Belgium. 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?
AUC inf (time frame: 48 hours post dose). The study lists 3 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 19 Aug 2015.