This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single dose of tofacitinib 5 mg tablet
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)
New Haven Clinical Research Unit
New Haven, Connecticut, United States
AUCinf for tofacitinib oral solution and tofacitinib tablet
Area under the curve from time zero to extrapolated infinite time for both oral solution and tofacitinib.
Time frame: 24 hrs after study drug administration in Period 1 and Period 2
AUClast for tofacitinib oral solution and tofacitinib tablet
Area under the plasma concentration time curve from 0 to time of the last measurement of both the tofacitinib oral solution and tofacitinib tablet.
Time frame: 24 hrs after study drug administration in Period 1 and Period 2
Cmax for tofacitinib oral solution and tofacitinib tablet
Maximum observed plasma concentration for tofacitinib oral solution and tofacitinib tablet
Time frame: 24 hrs after study drug administration in Period 1 and Period 2
Number of subjects with adverse events (AEs).
Number of subjects with adverse events (AEs).
Time frame: Screening to up to 28-35 days after the last dose of study medication in Period 2.
Number of subjects with laboratory tests findings of potential clinical importance
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: Screening through Day 2 of Period 2
Number of subjects with clinically significant abnormal vital signs
Number of subjects with clinically significant abnormal vital signs
Time frame: Screening through Day 2 of Period 2
Number of subjects with clinically significant physical examination findings
Number of subjects with clinically significant physical examination findings.
Time frame: Screening to Day 2 of Period 2
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