Rheumatoid ArthritisPhase 1NCT01184001

A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects

A Phase 1 study testing Treatment A and Treatment B in people with Rheumatoid Arthritis, run by Pfizer at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Treatment A and Treatment B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSingapore
Study dates: Sep 2010to Sep 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.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 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.
Evidence or history of any clinically significant infections within the past 3 months.
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.

Singapore1 site

Pfizer Investigational Site
Singapore, 188770

Other trials in Singapore

About this study

Official title: A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects

In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

Read the detailed description

To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).

Conditions: Rheumatoid Arthritis
Being tested: Treatment A, Treatment B
Keywords: Healthy subjects, Food Effect Study
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment ADrug
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
Treatment BDrug
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Treatment BDrug
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Treatment ADrug
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Study groups in NCT01184001
Study group	Role	What they receive
Sequence 1	Experimental	Not described Receives: Drug: Treatment A; Drug: Treatment B
Sequence 2	Experimental	Not described Receives: Drug: Treatment B; Drug: Treatment A

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCinf and Cmax of tasocitinib (CP-690,550).
Measured: PK blood samples out to 24 hours post dose in each of two periods.

Secondary outcomes (4)

AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).
Measured: PK blood samples out to 24 hours post dose in each of two periods.
Safety: Laboratory tests.
Measured: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.
Safety:Vital signs.
Measured: Prior to dosing in Period 1 and 2.
Safety: AE reporting.
Measured: Continuous

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Sep 2010

First posted18 Aug 2010 (estimated)
Study startSep 2010
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid ArthritisStudies 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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01184001
Sponsor's protocol ID: A3921076
Status last verified: Oct 2010
First submitted: 17 Aug 2010
Last updated: 13 Oct 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects
ClinicalTrials.gov ID: NCT01184001
Acronym / sponsor ID: A3921076
Conditions: Rheumatoid Arthritis
Keywords: Healthy subjects, Food Effect Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 18 Aug 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.

Detailed description

To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1	Experimental	Drug: Treatment A, Drug: Treatment B
Sequence 2	Experimental	Drug: Treatment B, Drug: Treatment A

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 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.
Evidence or history of any clinically significant infections within the past 3 months.
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
Treatment ASingle dose of tasocitinib (CP-690,550) 10 mg under fed conditions.	Drug	Sequence 1
Treatment BSingle dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.	Drug	Sequence 1
Treatment BSingle dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.	Drug	Sequence 2
Treatment ASingle dose of tasocitinib (CP-690,550) 10 mg under fed conditions.	Drug	Sequence 2

Primary outcome

AUCinf and Cmax of tasocitinib (CP-690,550).
Time frame: PK blood samples out to 24 hours post dose in each of two periods.

4 secondary outcomes

AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).
Time frame: PK blood samples out to 24 hours post dose in each of two periods.
Safety: Laboratory tests.
Time frame: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.
Safety:Vital signs.
Time frame: Prior to dosing in Period 1 and 2.
Safety: AE reporting.
Time frame: Continuous

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 13 Oct 2010.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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 Treatment A and Treatment B in people with Rheumatoid Arthritis, 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 3 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 13 Oct 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 and Cmax of tasocitinib (CP-690,550). (time frame: PK blood samples out to 24 hours post dose in each of two periods.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01184001.

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 13 Oct 2010.