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The purpose of this study is to learn if a medicine called itraconazole changes how the body processes the study medicine (PF-08642534) in healthy adults.
This study is seeking healthy participants (men or women) who:
Participants will receive single doses of the study medicine (PF-08642534) with and without itraconazole.
The total planned time of participation is about 12 weeks. The study consists of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1--PF-08642534 | Experimental | Participants will receive a single dose of PF-08642534 |
|
| Period 2--itraconazole plus PF-08642534 | Experimental | Participants will receive single doses of PF-08642534) in presence of itraconazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08642534 | Drug | Participants will receive a single dose of PF-08642534 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0 to 240 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent Adverse Events | Baseline up to approximately 8 weeks |
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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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|
| 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 once daily for 13 days (Day 12 to Day 24) |
|
| D010879 |
| Piperazines |