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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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NCT01143805

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01143805
Pfizer
Completed
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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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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Tasocitinib 10 mg oral tablet
    Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
  • 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
  • Experimental: Treatment A: Tasocitinib 10 mg oral tablet
    Intervention: Drug: Tasocitinib 10 mg oral tablet
  • Experimental: Treatment B: Tasocitinib 10 mg IV Infusion
    Intervention: Drug: Tasocitinib 10 mg IV Infusion
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2010
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01143805
A3921077
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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