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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tasocitinib 10 mg oral tablet; Drug: Tasocitinib 10 mg IV Infusion

• Registration Number: NCT01143805
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Study Start: 2010-07
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-06
• Last Update Posted: 2010-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: Tasocitinib 10 mg oral tablet	Tasocitinib 10 mg oral tablet	-
Treatment B: Tasocitinib 10 mg IV Infusion	Tasocitinib 10 mg IV Infusion	-

Primary Outcome Measures

Name	Time	Method
AUCinf of tasocitinib (CP 690,550)	PK blood samples out to 12 hours post dose

Secondary Outcome Measures

Name	Time	Method
AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).	PK blood samples out to 12 hours postdose
Safety Laboratory tests: hematology, chemistry, urine testing	Safety Laboratory testing performed out to 2 days post last dose
Vital Signs: Blood pressure, heart rate, oral temperature	Vital signs out to 2 days post last dose
AE Reporting	Throughout study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore