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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01499004
First received: November 23, 2011
Last updated: January 11, 2012
Last verified: January 2012
History of Changes

November 23, 2011
January 11, 2012
November 2011
December 2011   (final data collection date for primary outcome measure)
  • AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • AUCinf: Area under the plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01499004 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01499004
A3921131
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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