HealthyPhase 1NCT01143805
A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form
A Phase 1 study testing Tasocitinib 10 mg oral tablet and Tasocitinib 10 mg IV Infusion in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). 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?
- Tasocitinib 10 mg oral tablet and Tasocitinib 10 mg IV Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Aug 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 >50 kg (110 lbs)
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Who cannot join
- Evidence or history of any clinically significant illness, medical condition, or disease.
- 2. Evidence or history of any clinically significant infections within the past 3 months.
- 3. 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: A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects
In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.
Read the detailed description
To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
- Conditions
- Healthy
- Being tested
- Tasocitinib 10 mg oral tablet, Tasocitinib 10 mg IV Infusion
- Keywords
- Absolute Bioavailability, 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.
Tasocitinib 10 mg oral tabletDrug
Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
Tasocitinib 10 mg IV InfusionDrug
Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Tasocitinib 10 mg oral tablet | Experimental | Not described Receives: Drug: Tasocitinib 10 mg oral tablet |
| Treatment B: Tasocitinib 10 mg IV Infusion | Experimental | Not described Receives: Drug: Tasocitinib 10 mg IV Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of tasocitinib (CP 690,550)
Measured: PK blood samples out to 12 hours post dose
Secondary outcomes (4)
AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).
Measured: PK blood samples out to 12 hours postdose
Safety Laboratory tests: hematology, chemistry, urine testing
Measured: Safety Laboratory testing performed out to 2 days post last dose
Vital Signs: Blood pressure, heart rate, oral temperature
Measured: Vital signs out to 2 days post last dose
AE 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 posted14 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT01143805
- Sponsor's protocol ID
- A3921077
- Status last verified
- Aug 2010
- First submitted
- 9 Jun 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01143805
- Acronym / sponsor ID
- A3921077
- Conditions
- Healthy
- Keywords
- Absolute Bioavailability, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jun 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 CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.
Detailed description
To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Tasocitinib 10 mg oral tablet | Experimental | Drug: Tasocitinib 10 mg oral tablet |
| Treatment B: Tasocitinib 10 mg IV Infusion | Experimental | Drug: Tasocitinib 10 mg IV Infusion |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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 >50 kg (110 lbs)
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Key exclusion criteria (3 listed)
- Evidence or history of any clinically significant illness, medical condition, or disease.
- 2. Evidence or history of any clinically significant infections within the past 3 months.
- 3. 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 |
|---|---|---|
| Tasocitinib 10 mg oral tabletTreatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet | Drug | Treatment A: Tasocitinib 10 mg oral tablet |
| Tasocitinib 10 mg IV InfusionTreatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion | Drug | Treatment B: Tasocitinib 10 mg IV Infusion |
Primary outcome
AUCinf of tasocitinib (CP 690,550)
Time frame: PK blood samples out to 12 hours post dose
4 secondary outcomes
AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).
Time frame: PK blood samples out to 12 hours postdose
Safety Laboratory tests: hematology, chemistry, urine testing
Time frame: Safety Laboratory testing performed out to 2 days post last dose
Vital Signs: Blood pressure, heart rate, oral temperature
Time frame: Vital signs out to 2 days post last dose
AE 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 10 Aug 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 Tasocitinib 10 mg oral tablet and Tasocitinib 10 mg IV Infusion 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 4 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 10 Aug 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?
AUCinf of tasocitinib (CP 690,550) (time frame: PK blood samples out to 12 hours post dose). 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 10 Aug 2010.