A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

Pfizer18 enrolled

Overview

This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Tofacitinib MR 22 mg (Fed)DRUG

A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal

Tofacitinib MR 22 mg (Fasted)DRUG

A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age; * Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; * Clinically significant infections within the past 3 months

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium