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New treatment option for Hepatic Impairment
Official title A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
ClinicalTrials.gov ID: NCT07269301
What this study is testing
What is PF-07328948?
PF-07328948 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatic impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Group 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
You likely can't join if
- 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...
- Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant...
- Use of specific prohibited prior/concomitant therapies
- Use of an investigational product within 30 days or 5 half-lives (whichever longer).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lake Forest, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lake Forest, California, United States; Orlando, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.