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

June 9, 2010
August 6, 2010
July 2010
August 2010   (final data collection date for primary outcome measure)
AUCinf of tasocitinib (CP 690,550) [ Time Frame: PK blood samples out to 12 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01143805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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.

Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01143805
A3921077
No
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