A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550

Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions

In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B

Detailed Description

This is a bioequivalence study for CP-690,550.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 >45 kg (99 lbs).
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Personal or family history of hereditary immunodeficiency (eg, severe - Evidence of any clinically significant illness, medical condition, or disease.

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1	Drug: Treatment A; Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets); Drug: Treatment B; Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Experimental: Sequence 2	Drug: Treatment A; Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets); Drug: Treatment B; Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK parameters: AUCinf, AUClast and Cmax of CP-690,550	PK blood samples out to 24 hours post dose in each period

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameters: Tmax, AUCt and half-life of CP-690,550	Derived from PK blood samples out to 24 hours post dose in each period
Safety: laboratory tests	Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
Safety: vital signs	Prior to dosing in each period and at 24 hours post last dose in Period 2
Safety: adverse event reporting	Throughout study

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 13, 2011
• First Submitted That Met QC Criteria: January 13, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2011
• Last Update Submitted That Met QC Criteria: April 6, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Bioequivalence; Rheumatoid Arthritis; healthy volunteer study
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: A3921135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No