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The purpose of the study is to learn how itraconazole changes how the body processes the 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 itraconazole.
Itraconazole 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 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 itraconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07248144 with and without Itraconazole | Experimental | Period 1; PF-07248144 single dose, oral tablet on Day 1. Period 2; Itraconazole oral solution once daily on Days 1-12 plus PF-07248144 single dose, oral tablet on Day 4. Period 1 and Period 2 will be separated with a washout of at least 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07248144 | Drug | Participants will receive PF-07248144 as a single dose, oral tablet on Day 1 of Period 1 and Day 4 of Period 2 with a washout period between two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for PF-07248144 | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose | |
| Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for PF-07248144 | AUClast will be used as the primary endpoint if AUCinf cannot be reliably estimated | 0 (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) for PF-07248144 | 0 (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 participants with treatment-emergent adverse events | From baseline up to 28 to 35 days post last study intervention dose | |
| Number of participants with laboratory test abnormalities | From baseline up to 28 to 35 days post last study intervention dose |
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Inclusion
Exclusion
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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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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Participants will receive Itraconazole oral solution once daily on Days 1-12 in Period 2 |
|
| Number of participants with vital signs values meeting categorical summarization criteria | From baseline up to 28 to 35 days post last study intervention dose |
| Number of participants with clinically significant physical examination abnormalities | From baseline up to 28 to 35 days post last study intervention dose |
| Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements | From baseline up to 28 to 35 days post last study intervention dose |
| D010879 |
| Piperazines |