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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
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Tasocitinib 10 mg oral tablet Drug: Tasocitinib 10 mg IV Infusion Phase 1

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
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. AUCinf of tasocitinib (CP 690,550) [ Time Frame: PK blood samples out to 12 hours post dose ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety Laboratory tests: hematology, chemistry, urine testing [ Time Frame: Safety Laboratory testing performed out to 2 days post last dose ]
  3. Vital Signs: Blood pressure, heart rate, oral temperature [ Time Frame: Vital signs out to 2 days post last dose ]
  4. AE Reporting [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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