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Trial record 1 of 1 for:    NCT02084875
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084875
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE March 12, 2014
Last Update Posted Date November 30, 2018
Actual Study Start Date  ICMJE April 11, 2014
Actual Primary Completion Date May 25, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Area under the curve from time zero to infinity [ Time Frame: 48 hours post dose ]
    Area under the curve from time zero to infinity
  • Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration [ Time Frame: 48 hours post dose ]
    Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 hours post dose ]
    Maximum Observed Plasma Concentration (Cmax)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours post dose ]
    Time to peak concentration
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 48 hours post dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours post dose ]
    Time to pike concentration
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 48 hours post dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 25, 2014
Actual Primary Completion Date May 25, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02084875
Other Study ID Numbers  ICMJE A3921180
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP