A Phase 1 interventional study of vepdegestrant in Healthy Participants, sponsored by Pfizer. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Pfizer · Phase 1, Interventional, and Other
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
participants with normal hepatic function
Drug: vepdegestrant
participants with moderate hepatic impairment
Drug: vepdegestrant
participants with severe hepatic impairment
Drug: vepdegestrant
Vepdegestrant administered as a single oral 200 mg dose
Also known as: ARV-471, PF-07850327
Maximum observed concentration (Cmax) for vepdegestrant
Time frame: 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 - ∞).
Time frame: Pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 192, and 216 hours post dose
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 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
Time frame: 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 frame: 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 frame: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Plan to share: No — 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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