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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521924-31-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to learn how the study medicine called fluconazole changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how the medicine is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with fluconazole.
Fluconazole 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 10 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 fluconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07248144 | Experimental | PF-07248144 administered by mouth as a single dose in Period 1 and Period 2. Fluconazole administered by mouth once a day for 13 days in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07248144 | Drug | PF-07248144 administered by mouth as a single dose in Period 1 and Period 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose | |
| AUCinf of PF-07248144 - Period 2 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of PF-07248144 - Period 1 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose | |
| Cmax of PF-07248144 - Period 2 | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events (AE) by Severity | From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days). | |
| Number of Participants With Clinically Significant Clinical Laboratories Abnormalities |
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Inclusion Criteria
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 - 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 |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole | Drug | Fluconazole administered by mouth once a day for 13 days in Period 2. |
|
| From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days). |
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |
| Number of Participants With Abnormalities in Physical Examination | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days) |