Liver function may change how this drug works – early study begins
NCT ID NCT07269301
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This early-stage study by Pfizer looks at how different levels of liver function affect the processing of a new drug called PF-07328948. About 26 adults with and without liver impairment will take a single tablet and stay at the clinic for 6 days for monitoring and blood tests. The goal is to see if liver problems change how the drug moves through the body, which could guide future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-07328948 (a drug taken as a tablet)
- What this could lead to
- If successful, this study could help determine safe dosing of PF-07328948 for people with liver problems.
- What could go wrong
- This is a very early Phase 1 trial with only 26 participants, so results may not apply broadly. The drug may still fail in later studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, at the screening visit. * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lb). * Group 4 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests. * Group 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests. * Groups 1, 2 \& 3 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening. * Groups 1, 2 \& 3 only: stable concomitant medications for the management of individual participant's medical history. Exclusion Criteria: * Any condition possibly affecting drug absorption * At screening, a positive result for HIV antibodies. * Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition. * Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study. * Use of specific prohibited prior/concomitant therapies * Use of an investigational product within 30 days or 5 half-lives (whichever longer). * eGFR\<60 mL/min/1.73m2 at screening. * A positive urine drug test at screening or admission to study clinic. * At screening or admission to study clinic, a positive breath alcohol test. * History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. * Group 4 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C. * Group 4 only: screening ECG demonstrating QTcF interval \>450 ms or a QRS interval \>120 ms. * Group 4 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg * Group 1, 2 \& 3 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as \<1 year in Groups 2 \& 3 and \<6 months for Group 1 only). * Group 1, 2 \& 3 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI. * Group 1, 2 \& 3 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening. * Group 1, 2 \& 3 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy * Groups 1, 2 \& 3 only: severe ascites and/or pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment. * Groups 1, 2 \& 3 only: previously received a kidney, liver, or heart transplant. * Groups 1, 2, \& 3 only: screening ECG demonstrating a QTcF interval \>470 ms or a QRS interval \>120 ms. * Groups 1, 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1. * Groups 1, 2 \& 3 only: ALT or AST \>5x upper limit of normal on clinical laboratory tests at screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Genesis Clinical Research, LLC
RECRUITINGTampa, Florida, 33603, United States
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Orange County Research Center
RECRUITINGLake Forest, California, 92630, United States
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Orlando Clinical Research Center
RECRUITINGOrlando, Florida, 32809, United States
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