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CompletedNCT01143805Updated Aug 10, 2010

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 interventional study of Tasocitinib 10 mg oral tablet and Tasocitinib 10 mg IV Infusion in Healthy, sponsored by Pfizer. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-10.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Absolute Bioavailability
  • Rheumatoid Arthritis
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Evidence or history of any clinically significant illness, medical condition, or disease.

    1. Evidence or history of any clinically significant infections within the past 3 months.
    1. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Treatment A: Tasocitinib 10 mg oral tablet

    Drug: Tasocitinib 10 mg oral tablet

  • Experimental
    Treatment B: Tasocitinib 10 mg IV Infusion

    Drug: Tasocitinib 10 mg IV Infusion

Interventions

  • DrugTasocitinib 10 mg oral tablet

    Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet

  • DrugTasocitinib 10 mg IV Infusion

    Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion

06

What researchers measure

Primary outcomes

  1. AUCinf of tasocitinib (CP 690,550)

    Time frame: PK blood samples out to 12 hours post dose

Secondary outcomes

  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

07

Study locations

1 site
  • Pfizer Investigational Site
    Singapore, 188770, Singapore
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01143805
Lead sponsor
Pfizer
First posted
Jun 14, 2010
Start date
Jul 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Aug 10, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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