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 Overview
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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.

Official Title
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A Phase 1, Randomized, Open Label, Single Dose, 2-Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (MR) 11 Mg Tablets In Healthy Western And Japanese Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: tofacitinib modified-release (MR) formulation
* Drug: tofacitinib modified-release (MR) formulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tofacitinib MR 11 mg Fed<br>tofacitinib modified release (MR) 11 mg tablet administered with food. | Drug: tofacitinib modified-release (MR) formulation<br>* A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.<br>|
| Experimental: tofacitinib MR 11 mg Fasting<br>tofacitinib modified release (MR) 11 mg tablet administered without food. | Drug: tofacitinib modified-release (MR) formulation<br>* tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from time zero to infinity | Area under the curve from time zero to infinity | 48 hours post dose | 
| Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration | Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration | 48 hours post dose | 
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | 48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to peak concentration | 48 hours post dose | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 48 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect, pharmacokinetic, healthy volunteer