A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: tofacitinib modified-release (MR) formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02084875

A3921180

Details and patient eligibility

About

This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 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 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers and/or healthy females volunteers of non-childbearing potential who are 18 to 55 years of age;
Healthy volunteers who are of Japanese or Western descent;
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