vepdegestrant
DrugVepdegestrant administered as a single oral 200 mg dose
Other names: ARV-471, PF-07850327
NCT Number: NCT07231991
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:
* females who cannot have children or males * between 18 and 70 years of age * weigh more than 50 Kilograms (110 pounds) * either healthy with normal liver function or have loss of liver function
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 1
Clinical Pharmacology of Miami, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Vepdegestrant administered as a single oral 200 mg dose
Other names: ARV-471, PF-07850327
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
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
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: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF VEPDEGESTRANT (PF-07850327) IN ADULT PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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