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
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ClinicalTrials.gov Identifier: NCT01143805 |
Recruitment Status
:
Completed
First Posted
: June 14, 2010
Last Update Posted
: August 10, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Tasocitinib 10 mg oral tablet Drug: Tasocitinib 10 mg IV Infusion | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment A: Tasocitinib 10 mg oral tablet |
Drug: Tasocitinib 10 mg oral tablet
Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
|
Experimental: Treatment B: Tasocitinib 10 mg IV Infusion |
Drug: Tasocitinib 10 mg IV Infusion
Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
|
- AUCinf of tasocitinib (CP 690,550) [ Time Frame: PK blood samples out to 12 hours post dose ]
- 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 ]

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
-
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143805
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT01143805 History of Changes |
Other Study ID Numbers: |
A3921077 |
First Posted: | June 14, 2010 Key Record Dates |
Last Update Posted: | August 10, 2010 |
Last Verified: | August 2010 |
Keywords provided by Pfizer:
Absolute Bioavailability Rheumatoid Arthritis |
Additional relevant MeSH terms:
Tofacitinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |