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Trial record 1 of 1 for:    NCT02487433
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A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02487433
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • AUC inf [ Time Frame: 48 hours post dose ]
    Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
  • AUC last [ Time Frame: 48 hours post dose ]
    Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
  • 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: June 29, 2015)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours post dose ]
  • Plasma Decay Half-Life (t 1/2) [ 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 Same as current
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 22 Milligram Tablets In Healthy 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) 22 Mg Tablets In Healthy Volunteers
Brief Summary 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.
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 MR 22 mg (Fed)
    A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
  • Drug: Tofacitinib MR 22 mg (Fasted)
    A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
Study Arms  ICMJE
  • Experimental: Tofacitinib MR 22 mg Fed
    Single dose of tofacitinib MR 22 mg administered under fed conditions
    Intervention: Drug: Tofacitinib MR 22 mg (Fed)
  • Experimental: Tofacitinib MR 22 mg Fasted
    Single dose of tofacitinib MR 22 mg administered under fasted conditions
    Intervention: Drug: Tofacitinib MR 22 mg (Fasted)
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: June 29, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487433
Other Study ID Numbers  ICMJE A3921217
2014-005056-26 ( EudraCT Number )
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 August 2015

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