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

Sponsor
Pfizer
Study ID
NCT01499004
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Jan 2012
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    tofacitinib (CP-690,550) modified-release formulation A-Fed
  • Experimental: Treatment B
    tofacitinib (CP-690,550) modified-release formulation B1-Fed
  • Experimental: Treatment C
    tofacitinib (CP-690,550) modified-release formulation A-Fasted
  • Experimental: Treatment D
    tofacitinib (CP-690,550) modified-release formulation B1-Fasted
  • Experimental: Treatment E
    tofacitinib (CP-690,550) modified-release formulation B2-Fasted
  • Experimental: Treatment F
    tofacitinib (CP-690,550) immediate-release formulation-Fasted

Primary Outcome Measure

AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time [ Time Frame: 72 hours post dose ]

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