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

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

AUCinf of tasocitinib (CP 690,550)

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

Secondary Outcomes

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

Safety Laboratory tests: hematology, chemistry, urine testing

Time frame: 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

AE Reporting

Time frame: Throughout study