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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 the body processes a study medicine called vepdegestrant in participants with loss of liver function relative to people with normal liver function.
This study is seeking participants who are:
All participants in this study will take one dose of vepdegestrant by mouth. This study looks at how the medicine is changed and removed from the body after being taken by the participants. The amount of vepdegestrant in participants with loss of liver function will be compared to the amount of vepdegestrant in participants with normal liver function.
All participants will stay at the study clinic for about 11 days and 10 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | participants with normal hepatic function |
|
| Group 2 | Experimental | participants with moderate hepatic impairment |
|
| Group 3 | Experimental | participants with severe hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vepdegestrant | Drug | Vepdegestrant administered as a single oral 200 mg dose |
|
| 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, 192, and 216 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, 192, and 216 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Time from baseline 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 Clinical Laboratory Abnormalities |
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Inclusion criteria including but not limited to:
Normal hepatic function group only:
-Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.
Hepatic impairment groups only:
Exclusion criteria including but not limited to:
Normal hepatic function group only:
-Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Hepatic impairment groups only:
-A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Recruiting | Miami | Florida | 33172 | 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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| Time from baseline 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 from baseline 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 Electrocardiogram (ECG) Abnormalities | Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention. |
| Floridian Clinical Research, LLC |
| Recruiting |
| Miami Lakes |
| Florida |
| 33016 |
| United States |
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
| Genesis Clinical Research, LLC | Recruiting | Tampa | Florida | 33603 | United States |