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New treatment option for Renal Impairment
Official title A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
ClinicalTrials.gov ID: NCT07315360
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 renal 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 learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function. The study will include participants who: Are aged 18 to 80 years.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 80. Healthy volunteers may be eligible.
You may be able to join if
- Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.
- BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lbs).
- Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.
- Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure...
- Group 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from the screening visits.
You likely can't join if
- Any condition possibly affecting drug absorption.
- At screening, a positive result for HIV antibodies.
- History of renal, liver, or heart transplantation.
- Urinary incontinence without catheterization.
- Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic...
- 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 and 80 years, at the screening visit.
- BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lbs).
- Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.
- Group 1 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 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from the screening visits.
- Groups 2 \& 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.
- Groups 2 \& 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):
- Severe RI: 15 ≤ mean eGFR \<30 mL/min, not requiring hemodialysis.
- Moderate RI: 30 ≤ mean eGFR \<60 mL/min.
- Any condition possibly affecting drug absorption.
- At screening, a positive result for HIV antibodies.
- History of renal, liver, or heart transplantation.
- Urinary incontinence without catheterization.
- Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
- Use of an investigational product within 30 days or 5 half-lives (whichever longer).
- A positive urine drug test or breath alcohol test at screening or admission to study clinic.
- Group 1 only: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Group 1 only: screening ECG demonstrating QTcF interval \>450 ms or a QRS interval \>120 ms.
- Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
- Group 2 \& 3 only: presence of acute renal disease
- Group 2 \& 3 only: requiring dialysis or anticipated need for dialysis
- Group 2 \& 3 only: listed for solid organ transplantation
- Groups 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.
- Groups 2 \& 3 only: screening ECG demonstrating a QTcF interval \>470 ms or a QRS interval \>120 ms.
- Groups 2 \& 3 only: unstable medical conditions or comorbidities that would interfere with study participation
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
- Saint Paul, Minnesota, 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 80 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; Saint Paul, Minnesota, 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.