Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01143805
First received: June 9, 2010
Last updated: August 6, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Tasocitinib 10 mg oral tablet
Drug: Tasocitinib 10 mg IV Infusion
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of tasocitinib (CP 690,550) [ Time Frame: PK blood samples out to 12 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety Laboratory tests: hematology, chemistry, urine testing [ Time Frame: Safety Laboratory testing performed out to 2 days post last dose ] [ Designated as safety issue: Yes ]
  • Vital Signs: Blood pressure, heart rate, oral temperature [ Time Frame: Vital signs out to 2 days post last dose ] [ Designated as safety issue: Yes ]
  • AE Reporting [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Enrollment: 12
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143805

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01143805     History of Changes
Other Study ID Numbers: A3921077
Study First Received: June 9, 2010
Last Updated: August 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Absolute Bioavailability
Rheumatoid Arthritis

Additional relevant MeSH terms:
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015