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The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults.
This study will happen in 2 periods. The purpose of Period 1 of the study is to understand how the medicine is changed and eliminated from the body after it is taken) and safety of a single dose of PF-07220060.
The purpose of Period 2 of the study is to understand how the medicine is changed and eliminated from the body after it is taken and safety of a single dose of PF-07220060 following multiple days dosing carbamazepine twice a day.
Multiple blood samples will be collected in each period up to 120 hours after the PF-07220060 dose in order to measure the amount of PF-07220060 in the blood. On Day 1 in Period 1, a single oral dose of PF-07220060 will be administered with food. Period 2 will begin following the last blood sample collection in Period 1. Carbamazepine will be dosed in Period 2 at 100 mg twice a day on Days 1, 2, and 3, and then, will increase to 200 mg twice a day on Days 4, 5, 6, and 7, and will eventually increase to and be maintained at 300 mg twice a day for the rest of Period 2 from Day 8 to Day 18. On Day 14 in Period 2, a single oral dose of PF-07220060 will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Single dose PF-07220060 alone |
|
| Period 2 | Experimental | Single dose PF-07220060 given after multiple doses of carbamazepine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07220060 | Drug | Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose. | |
| Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC) | Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laboratory Abnormalities | From baseline up to 28 to 35 days after last dose of investigational drug | |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | From baseline up to 28 to 35 days after last dose of investigational drug |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | 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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This is an open-label, fixed sequence, two-period, crossover study in healthy participants.
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Open label
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| Carbamazepine ER Tablet | Drug | Carbamazepine dosing titration regimen in Period 2 from Day 1 to 18 |
|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From baseline up to 28 to 35 days after last dose of investigational drug |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 28 to 35 days after last dose of investigational drug |