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

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Treatment B; Drug: Treatment A

• Registration Number: NCT01277991
• Lead Sponsor: Pfizer

Brief Summary

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 .

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Study Start: 2011-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Treatment A	-
Sequence 1	Treatment A	-
Sequence 2	Treatment B	-
Sequence 1	Treatment B	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety: vital signs	Prior to dosing in each period and at 24 hours post last dose in Period 2
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: adverse event reporting	Throughout study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore