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

August 6, 2010 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCinf of tasocitinib (CP 690,550)
Time Frame: PK blood samples out to 12 hours post dose
PK blood samples out to 12 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Vital signs out to 2 days post last dose
AE Reporting
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 6, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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