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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522331-34-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to learn how the study medicine called carbamazepine changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with carbamazepine.
Carbamazepine can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 8 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with carbamazepine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07248144 with and without Carbamazepine | Experimental | PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14. Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07248144 | Drug | Participants will receive a single dose of PF-07248144 by mouth in Period 1 on Day 1 and Period 2 on Day 14, with a washout period of at least 14 days between two doses of PF-07248144 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Period 1 | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose | |
| Cmax Period 2 | Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Period 1 | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose | |
| AUCinf Period 2 | Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast). Period 1. To be used as the primary endpoint if AUCinf cannot be reliably estimated | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose | |
| AUClast. Period 2. To be used as the primary endpoint if AUCinf cannot be reliably estimated | Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Treatment-Related AEs by Severity | From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) | |
| Number of Participants With Laboratory Test Abnormalities | From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) |
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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 - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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 |
|---|---|
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | Participants will receive Carbamazepine by mouth once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2. |
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| Number of Participants With Clinically Significant Physical Examination Abnormalities | From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) |
| Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) |
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters | From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days) |