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

NCT ID: NCT01143805

Last Updated: 2010-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-08-31

Brief 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment A: Tasocitinib 10 mg oral tablet

Group Type: EXPERIMENTAL

Tasocitinib 10 mg oral tablet

Intervention Type: DRUG

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

Treatment B: Tasocitinib 10 mg IV Infusion

Group Type: EXPERIMENTAL

Tasocitinib 10 mg IV Infusion

Intervention Type: DRUG

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

Interventions

Tasocitinib 10 mg oral tablet

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Singapore, , Singapore

Countries

Singapore

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921077&StudyName=A%20Study%20To%20Estimate%20The%20Amount%20Of%20CP-690%2C550%20%28Study%20Drug%29%20That%20Is%20Absorbed%20Into%20The%20Blood%20Of%20Healthy%20Subjects%20Following%20Oral%20A

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Other Identifiers

A3921077

Identifier Type: -

Identifier Source: org_study_id