HealthyPhase 1NCT01731327
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
A Phase 1 study testing tofacitinib modified-release (MR) formulation in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers. 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 modified-release (MR) formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2012to Dec 2012
- 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 female 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, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers
This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
- Conditions
- Healthy
- Being tested
- tofacitinib modified-release (MR) formulation
- Keywords
- Phase 1, relative bioavailability, modified release, tofacitinib, CP-690, 550, pharmacokinetic
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 11 mg tofacitinib modified-release (MR) administered in a fasting state.
tofacitinib modified-release (MR) formulationDrug
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment A | Experimental | A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. Receives: Drug: tofacitinib modified-release (MR) formulation |
| Experimental Treatment B | Experimental | A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. Receives: Drug: tofacitinib modified-release (MR) formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
Measured: 72 hours post dose
Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
Measured: 72 hours post dose
Secondary outcomes (6)
AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
Measured: 72 hours post dose
AUCinf: Area Under the Curve From Time Zero to Infinity
Measured: 72 hours post dose
Cmax: Maximum Observed Plasma Concentration
Measured: 72 hours post dose
AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
Measured: 72 hours post dose
Tmax: Amount of time drug takes to reach Cmax
Measured: 72 hours post dose
t ½: Terminal elimination half-life
Measured: 72 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 posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- 20 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
- NCT01731327
- Sponsor's protocol ID
- A3921132
- Status last verified
- Dec 2012
- First submitted
- 14 Nov 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01731327
- Acronym / sponsor ID
- A3921132
- Conditions
- Healthy
- Keywords
- Phase 1, relative bioavailability, modified release, tofacitinib, CP-690, 550, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Nov 2012 (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 single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment A | Experimental | Drug: tofacitinib modified-release (MR) formulationA single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. |
| Experimental Treatment B | Experimental | Drug: tofacitinib modified-release (MR) formulationA single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. |
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 female 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 modified-release (MR) formulationA single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. | Drug | Experimental Treatment A |
| tofacitinib modified-release (MR) formulationA single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. | Drug | Experimental Treatment B |
Primary outcome
AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
Time frame: 72 hours post dose
Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
Time frame: 72 hours post dose
6 secondary outcomes
AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
Time frame: 72 hours post dose
AUCinf: Area Under the Curve From Time Zero to Infinity
Time frame: 72 hours post dose
Cmax: Maximum Observed Plasma Concentration
Time frame: 72 hours post dose
AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
Time frame: 72 hours post dose
Tmax: Amount of time drug takes to reach Cmax
Time frame: 72 hours post dose
t ½: Terminal elimination half-life
Time frame: 72 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 24 Dec 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 modified-release (MR) formulation 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 24 Dec 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(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized (time frame: 72 hours post dose). The study lists 2 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 24 Dec 2012.