NCT07315360 A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
| NCT ID | NCT07315360 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Renal Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2027-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2026-01-28 with a primary completion date of 2027-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. * Either have normal kidney function or long-term reduced kidney function (moderate or severe). * Have a BMI (body mass index) of 17.5 to 40 kilogram per meter squared, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. All participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call. The study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.
Eligibility Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07315360 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Renal Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07315360 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07315360 currently recruiting?
Yes, NCT07315360 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07315360 trial being conducted?
This trial is being conducted at Lake Forest, United States, Orlando, United States, Tampa, United States, Saint Paul, United States.
Who is sponsoring the NCT07315360 clinical trial?
NCT07315360 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 28 participants.