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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-11

Study Completion Date

2014-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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tofacitinib MR 11 mg Fed

tofacitinib modified release (MR) 11 mg tablet administered with food.

Group Type EXPERIMENTAL

tofacitinib modified-release (MR) formulation

Intervention Type DRUG

A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.

tofacitinib MR 11 mg Fasting

tofacitinib modified release (MR) 11 mg tablet administered without food.

Group Type EXPERIMENTAL

tofacitinib modified-release (MR) formulation

Intervention Type DRUG

tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.

Interventions

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tofacitinib modified-release (MR) formulation

A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.

Intervention Type DRUG

tofacitinib modified-release (MR) formulation

tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes