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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:12/2/2018
Start Date:April 11, 2014
End Date:May 25, 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
1
site
Glendale Adventist Medical Center
Glendale, California 91206
?
mi
from
Glendale, CA
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