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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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 |
|
| Arm 2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib tablet | Drug | Single dose of tofacitinib 5 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24 hrs after study drug administration in Period 1 and Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for tofacitinib oral solution and tofacitinib tablet | Maximum observed plasma concentration for tofacitinib oral solution and tofacitinib tablet | 24 hrs after study drug administration in Period 1 and Period 2 |
| Number of subjects with adverse events (AEs). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38298058 | Derived | Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| Tofacitinib Oral Solution |
| Drug |
Single 5 mL dose of tofacitinib oral solution (1 mg/mL) |
|
Number of subjects with adverse events (AEs). |
| 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 | 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 | 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. | Screening to Day 2 of Period 2 |