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This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06651600 | Experimental | PF-06651600 200 milligrams(mg) once daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 | Drug | oral PF-06651600 tablet 200 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single dose: maximum observed concentration (Cmax) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: time to reach maximum concentration (Tmax) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: terminal half life (t1/2) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose:AUC24 | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: mean residence time (MRT) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: apparent volume of distribution (Vz/F) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 | |
| Single dose: apparent oral clearance (CL/F) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1 |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| North District of Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917289 | Derived | Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2. |
| 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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| Multiple Dose: Cmax | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: Tmax | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: AUCtau (tau = 24 hours) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: t1/2 | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: accumulation ratio on AUCtau (Rac) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: accumulation ratio on Cmax(Rac, Cmax) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: lowest concentration observed during the dosing interval (Cmin) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: average concentration at steady state (Cav) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: MRT | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: apparent volume of distribution at steady state (Vss/F) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: CL/F | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: peak trough fluctuation (PTF) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: peak trough swing (PTS) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Multiple Dose: predicted accumulation ratio to estimate linearity (Rss) | 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10 |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | From Day1 till Day17 |
| Number of participants with clinically significant change in vital signs from Baseline | From Day1 till Day17 |
| Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs) | From Day1 till Day17 |
| Number of participants with clinically significant abnormalities in physical examination findings | From Day1 till Day17 |
| Beijing |
| 100089 |
| China |