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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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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 22 mg Fed

Single dose of tofacitinib MR 22 mg administered under fed conditions

Group Type EXPERIMENTAL

Tofacitinib MR 22 mg (Fed)

Intervention Type 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

Single dose of tofacitinib MR 22 mg administered under fasted conditions

Group Type EXPERIMENTAL

Tofacitinib MR 22 mg (Fasted)

Intervention Type DRUG

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

Interventions

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Tofacitinib MR 22 mg (Fed)

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

Intervention Type DRUG

Tofacitinib MR 22 mg (Fasted)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes