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The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3). |
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| Treatment Sequence 2 | Experimental | PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3). |
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| Treatment Sequence 3 | Experimental | PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2). |
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| Treatment Sequence 4 | Experimental | PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 | Drug | PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600 | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. | |
| Maximum plasma PF-06651600 concentration (C max) | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600 | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. | |
| Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600 |
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Inclusion Criteria:
Exclusion Criteria:
Participants with any of the following acute or chronic infections or infection history:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States | ||
| Prism Research LLC dba Nucleus Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38267790 | Derived | Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9. |
| 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 |
|---|---|
| C000614924 | PF-06651600 |
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| Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. |
| Single dose plasma decay half-life (t 1/2) of PF-06651600 | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. |
| Single dose Apparent Oral Clearance (CL/F) of PF-06651600 | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. |
| Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600 | Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose. |
| Frequency of abnormal safety laboratory tests | Baseline up to day 9 |
| Frequency of Adverse Events | Baseline up to day 35 |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |