Actively Recruiting
A Phase 1, Open-Label, Single-Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of PF-07328948 in Adults with Kidney Impairment and Healthy Adults
Led by Pfizer · Updated on 2026-05-12
28
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the body processes the medicine PF-07328948 and how safe it is for adults with varying kidney function. The study includes adults aged 18 to 80 with normal or moderately to severely reduced kidney function, with specific body mass index and weight requirements. This research aims to understand how kidney function affects the medicine's behavior in the body, helping to guide safe use in people with kidney issues. All participants will take a single oral dose of PF-07328948 as one tablet. The study has three groups based on kidney function: those with normal kidneys, moderate impairment, and severe impairment. Each participant will receive the same dose. Participants will stay in a clinical research unit for about six days to take the medicine and undergo safety checks. Participants will be involved for up to 64 days, including screening, the inpatient stay, and a follow-up call. Researchers will collect blood samples at multiple time points after dosing to measure how much of the drug is unbound in the plasma. Monitoring for any side effects will continue up to 36 days after dosing to assess safety and tolerability.
CONDITIONS
Brief Title
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of nonchildbearing potential, aged 18 to 80 years at screening
- Body mass index between 17.5 and 40.0 kg/m2 inclusive
- Total body weight of at least 45 kilograms (99 pounds)
- Stable kidney function with less than or equal to 25% difference between two eGFR measurements
- Group 1 (normal kidney function): no clinically relevant abnormalities and mean eGFR of at least 90 mL/min
- Groups 2 and 3 (kidney impairment): good general health for chronic kidney impairment
- Group 2 (severe impairment): mean eGFR between 15 and less than 30 mL/min, not requiring hemodialysis
- Group 3 (moderate impairment): mean eGFR between 30 and less than 60 mL/min
You will not qualify if you...
- Any condition that could affect drug absorption
- Positive HIV antibody test at screening
- History of kidney, liver, or heart transplantation
- Urinary incontinence without catheterization
- Prothrombotic conditions or known genetic predisposition
- Use of investigational product within 30 days or 5 half-lives
- Positive urine drug or breath alcohol test at screening or admission
- Group 1 only: significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- Group 1 only: ECG abnormalities including QTcF interval greater than 450 ms or QRS interval greater than 120 ms
- Group 1 only: seated systolic blood pressure greater than or equal to 140 mm Hg or diastolic pressure greater than or equal to 90 mm Hg
- Groups 2 and 3 only: acute kidney disease
- Groups 2 and 3 only: requiring or anticipating need for dialysis
- Groups 2 and 3 only: listed for solid organ transplantation
- Groups 2 and 3 only: persistent severe, uncontrolled hypertension at screening or dosing
- Groups 2 and 3 only: ECG abnormalities with QTcF interval greater than 470 ms or QRS interval greater than 120 ms
- Groups 2 and 3 only: unstable medical conditions or comorbidities interfering with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 days
Participants receive a single oral dose of the study medicine PF-07328948 and undergo assessments to evaluate how their body processes the drug, as well as safety and tolerability monitoring.
1 dosing visit with multiple assessments over 120 hours post dose
Duration - Up to 36 days after dosing
Participants are monitored for any treatment-emergent adverse events up to 36 days after dosing to ensure safety.
Periodic follow-up visits until Day 36
Trial Site Locations
Total: 4 locations
1
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
3
Genesis Clinical Research, LLC
Tampa, Florida, United States, 33603
Actively Recruiting
4
Nucleus Network
Saint Paul, Minnesota, United States, 55114
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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