A Phase 1 interventional study of Tofacitinib MR 22 mg (Fed) and Tofacitinib MR 22 mg (Fasted) in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
Pfizer is the lead sponsor of 3,331 studies on the registry; 148 are open to participants now.
Of its 600 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Single dose of tofacitinib MR 22 mg administered under fed conditions
Drug: Tofacitinib MR 22 mg (Fed)
Single dose of tofacitinib MR 22 mg administered under fasted conditions
Drug: Tofacitinib MR 22 mg (Fasted)
A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
AUC inf
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
Time frame: 48 hours post dose
AUC last
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Time frame: 48 hours post dose
Cmax
Maximum observed plasma concentration (Cmax).
Time frame: 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 48 hours post dose
Plasma Decay Half-Life (t 1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 48 hours post dose
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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