HealthyPhase 1NCT02084875
A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
A Phase 1 study testing tofacitinib modified-release (MR) formulation in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 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 modified-release (MR) formulation
- 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 siteUnited States
- Study dates
- 11 Apr 2014to 25 May 2014
- 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 females volunteers of non-childbearing potential who are 18 to 55 years of age;
- Healthy volunteers who are of Japanese or Western descent;
- 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.
United States1 site
Glendale Adventist Medical Center
Glendale, California, 91206
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) 11 Mg Tablets In Healthy Western And Japanese Volunteers
This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 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 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
- Conditions
- Healthy
- Being tested
- tofacitinib modified-release (MR) formulation
- Keywords
- Food effect, pharmacokinetic, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tofacitinib modified-release (MR) formulationDrug
A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.
tofacitinib modified-release (MR) formulationDrug
tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| tofacitinib MR 11 mg Fed | Experimental | tofacitinib modified release (MR) 11 mg tablet administered with food. Receives: Drug: tofacitinib modified-release (MR) formulation |
| tofacitinib MR 11 mg Fasting | Experimental | tofacitinib modified release (MR) 11 mg tablet administered without food. Receives: Drug: tofacitinib modified-release (MR) formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to infinity
Area under the curve from time zero to infinity
Measured: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Measured: 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Measured: 48 hours post dose
Secondary outcomes (2)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to peak concentration
Measured: 48 hours post dose
Plasma Decay Half-Life (t1/2)
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 posted12 Mar 2014 (estimated)
- Study start11 Apr 2014
- Primary completion25 May 2014
- Study completion25 May 2014
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
- 24 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
- NCT02084875
- Sponsor's protocol ID
- A3921180
- Status last verified
- Nov 2018
- First submitted
- 10 Mar 2014
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. 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) 11 Mg Tablets In Healthy Western And Japanese Volunteers
- ClinicalTrials.gov ID
- NCT02084875
- Acronym / sponsor ID
- A3921180
- Conditions
- Healthy
- Keywords
- Food effect, pharmacokinetic, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2014 (actual)
- Primary completion
- 25 May 2014 (actual)
- Study completion
- 25 May 2014 (actual)
- First posted
- 12 Mar 2014 (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 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 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 11 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 11 mg Fed | Experimental | Drug: tofacitinib modified-release (MR) formulationtofacitinib modified release (MR) 11 mg tablet administered with food. |
| tofacitinib MR 11 mg Fasting | Experimental | Drug: tofacitinib modified-release (MR) formulationtofacitinib modified release (MR) 11 mg tablet administered without food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers and/or healthy females volunteers of non-childbearing potential who are 18 to 55 years of age;
- Healthy volunteers who are of Japanese or Western descent;
- 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 modified-release (MR) formulationA single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal. | Drug | tofacitinib MR 11 mg Fed |
| tofacitinib modified-release (MR) formulationtofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast. | Drug | tofacitinib MR 11 mg Fasting |
Primary outcome
Area under the curve from time zero to infinity
Time frame: 48 hours post dose
Area under the curve from time zero to infinity
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Time frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Maximum Observed Plasma Concentration (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 (t1/2)
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 30 Nov 2018.
- 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 modified-release (MR) formulation in people with Healthy, 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 3 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 30 Nov 2018. 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?
Area under the curve from time zero to infinity (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 30 Nov 2018.