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| Name | Class |
|---|---|
| Arvinas Estrogen Receptor, Inc. | INDUSTRY |
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The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.
This study looks at how the medicine is changed and removed from the body after a participant takes it.
This study is seeking for participant who:
The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose of vepdegestrant (3-period, 3-treatment, 6-sequence, crossover) | Experimental | Vepdegestrant administered as a single dose in Period 1, 2 and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single dose of vepdegestrant as tablet formulation (Treatment A) | Drug | phase 3 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) for vepdegestrant | Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose | |
| Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention. | |
| Number of Participants With Clinical Laboratory 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 |
|---|---|---|---|---|---|---|
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42371393 | Derived | Yang DZ, Matschke KT, WintonLee JAKC, Zhang Y, Tan W. A Relative Bioavailability Study of Vepdegestrant Tablets in Healthy Adult Participants. Eur J Drug Metab Pharmacokinet. 2026 Jun 29. doi: 10.1007/s13318-026-01018-w. Online ahead of print. |
| 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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| single dose of vepdegestrant as tablet formulation (Treatment B) | Drug | registration tablets |
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| single dose of vepdegestrant as tablet formulation (Treatment C) | Drug | registration tablets |
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| Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention. |