How vepdegestrant is processed in people with reduced liver function

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

This test gives a single oral dose of vepdegestrant to adults with normal or reduced liver function to see how their bodies process the medicine.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 4 sites (Miami, Florida and 3 other locations)
• Trial ID: NCT07231991 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial gives a single oral dose of vepdegestrant to adults with normal liver function and to adults with moderate or severe (Child-Pugh B or C) hepatic impairment. All participants must be male or female of non-childbearing potential, age 18–70, weigh over 50 kg, and stay at the clinic for about 11 days and 10 nights for blood sampling and monitoring. Investigators will measure drug concentrations over time to compare how vepdegestrant is absorbed, distributed, metabolized, and cleared in people with reduced liver function versus those with normal function. The goal is to generate pharmacokinetic data that can guide dosing and safety recommendations for patients with liver impairment.

Who should consider this trial

Good fit: Adults aged 18–70 who are male or female of non-childbearing potential, weigh more than 50 kg, and either have stable moderate-to-severe liver impairment or normal liver function are candidates.

Not a fit: People who are pregnant or able to become pregnant, younger than 18 or older than 70, weigh 50 kg or less, have unstable liver disease or other major medical problems, or cannot stay inpatient for the required 11 days are unlikely to benefit.

Why it matters

Potential benefit: If successful, the findings could help doctors choose safer and more effective vepdegestrant doses for people with liver impairment.

How similar studies have performed: Pharmacokinetic comparisons across liver function groups are a routine, well-established approach and have guided dosing for many other medicines, though vepdegestrant-specific data are limited.

Eligibility criteria

Inclusion criteria including but not limited to:

* Female participants of non-childbearing potential, or male participants between the age of 18 years (or the minimum age of consent in accordance with local regulations) and 70 years, inclusive, at screening.
* Body mass index of 17.5-38 kg/m2, inclusive, and a total body weight \>50 kg (110 lb).

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:

* Satisfy the criteria for Class B (Group 2: moderate hepatic impairment) or C (Group 3: severe hepatic impairment) of the modified Child-Pugh Classification.
* Stable hepatic impairment, defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.

Exclusion criteria including but not limited to:

* Any condition possibly affecting drug absorption.
* Use of prohibited prior or concomitant medications.

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.

Where this trial is running

Miami, Florida and 3 other locations

• Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (Recruiting)
• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Genesis Clinical Research, LLC — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Healthy Participants