Pfizer tests new drug in people with kidney problems
NCT ID NCT07315360
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how the medicine PF-07328948 moves through the body in adults with different levels of kidney function. About 28 people aged 18 to 80, with either normal kidneys or moderate-to-severe kidney problems, will take a single tablet. Researchers will check safety and drug levels over a 6-day stay and a follow-up call.
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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 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 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 80 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 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. Exclusion Criteria: * 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
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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
4 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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Nucleus Network
RECRUITINGSaint Paul, Minnesota, 55114, 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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