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Trial record 1 of 1 for:    NCT01499004
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A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01499004
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 23, 2011
First Posted Date  ICMJE December 26, 2011
Last Update Posted Date January 12, 2012
Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time [ Time Frame: 72 hours post dose ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ]
  • t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma [ Time Frame: 72 hours post dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • AUCinf: Area under the plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: 72 hours post dose ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ]
  • t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma [ Time Frame: 72 hours post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation [ Time Frame: 24 hours post dose ]
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 Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Brief Summary This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.
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 (CP-690,550) modified-release formulation A
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
  • Drug: tofacitinib (CP-690,550) modified-release formulation B1
    A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
  • Drug: tofacitinib (CP-690,550) modified-release formulation A
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
  • Drug: tofacitinib (CP-690,550) modified-release formulation B1
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
  • Drug: tofacitinib (CP-690,550) modified-release formulation B2
    A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
  • Drug: tofacitinib (CP-690,550) immediate-release formulation
    A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
Study Arms  ICMJE
  • Experimental: Treatment A
    tofacitinib (CP-690,550) modified-release formulation A-Fed
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation A
  • Experimental: Treatment B
    tofacitinib (CP-690,550) modified-release formulation B1-Fed
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B1
  • Experimental: Treatment C
    tofacitinib (CP-690,550) modified-release formulation A-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation A
  • Experimental: Treatment D
    tofacitinib (CP-690,550) modified-release formulation B1-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B1
  • Experimental: Treatment E
    tofacitinib (CP-690,550) modified-release formulation B2-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) modified-release formulation B2
  • Experimental: Treatment F
    tofacitinib (CP-690,550) immediate-release formulation-Fasted
    Intervention: Drug: tofacitinib (CP-690,550) immediate-release 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: December 21, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.

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 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01499004
Other Study ID Numbers  ICMJE A3921131
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 January 2012

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