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This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine and Ritlecitinib | Experimental | In Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet. In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | 100milligram (mg) tablet taken orally in period 1 and period 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine | Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Baseline through Day 28 | |
| Incidence of clinically significant abnormalities in vital signs | Baseline through Day 11 | |
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Inclusion Criteria:
-Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
-BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -
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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| 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 |
|---|---|
| D002110 | Caffeine |
| C000614924 | PF-06651600 |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Ritlecitinib |
| Other |
200 milligrams (mg) taken orally once a day(QD) for 8 days |
|
|
| Incidence of clinically significant abnormalities in clinical laboratory values |
| Baseline through Day 11 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |