A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

Part of paid clinical trials in Glendale, California.

Sponsor
Pfizer
Study ID
NCT02084875
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 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 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.

Key Dates

Start date
Apr 11, 2014
Status verified
Nov 2018
Primary completion
May 25, 2014
Completion
May 25, 2014

Study Design

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

Arms

  • Experimental: tofacitinib MR 11 mg Fed
    tofacitinib modified release (MR) 11 mg tablet administered with food.
  • Experimental: tofacitinib MR 11 mg Fasting
    tofacitinib modified release (MR) 11 mg tablet administered without food.

Primary Outcome Measure

Area under the curve from time zero to infinity [ Time Frame: 48 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Glendale Adventist Medical CenterGlendaleCalifornia91206-

Find similar trials in Glendale, CA

By research site
Glendale Adventist Medical Center· Glendale, CA

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