A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

Sponsor
Pfizer
Study ID
NCT02487433
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Tofacitinib MR 22 mg (Fed) — DRUG
    A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
  • Tofacitinib MR 22 mg (Fasted) — DRUG
    A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Aug 2015
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Tofacitinib MR 22 mg Fed
    Single dose of tofacitinib MR 22 mg administered under fed conditions
  • Experimental: Tofacitinib MR 22 mg Fasted
    Single dose of tofacitinib MR 22 mg administered under fasted conditions

Primary Outcome Measure

AUC inf [ Time Frame: 48 hours post dose ]

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