A Phase 1 interventional study of Tofacitinib tablet and Tofacitinib Oral Solution in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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).
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of 5 mL tofacitinib oral solution on Day 1 of Period 1 and Singe dose of 5 mg tofacitinib tablet on Day 1 of Period 2
Drug: Tofacitinib tablet · Drug: Tofacitinib Oral Solution
Single dose of 5 mg tofacitinib tablet on Day 1 of Period 1 and Singe dose of 5 mL tofacitinib oral solution on Day 1 of Period 2
Drug: Tofacitinib tablet · Drug: Tofacitinib Oral Solution
Single dose of tofacitinib 5 mg tablet
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)
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
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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