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Pfizer tests new drug in people with kidney problems

NCT ID NCT07315360

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Genesis Clinical Research, LLC

    RECRUITING

    Tampa, Florida, 33603, United States

  • Nucleus Network

    RECRUITING

    Saint Paul, Minnesota, 55114, United States

  • Orange County Research Center

    RECRUITING

    Lake Forest, California, 92630, United States

  • Orlando Clinical Research Center

    RECRUITING

    Orlando, Florida, 32809, United States

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