How vepdegestrant is processed in people with reduced liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.