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

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02084875
Pfizer
Completed
A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

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A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: 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.
  • Drug: tofacitinib modified-release (MR) formulation
    tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
  • Experimental: tofacitinib MR 11 mg Fed
    tofacitinib modified release (MR) 11 mg tablet administered with food.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
  • Experimental: tofacitinib MR 11 mg Fasting
    tofacitinib modified release (MR) 11 mg tablet administered without food.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02084875
A3921180
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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