Renal ImpairmentPhase 1NCT07315360
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
A Phase 1 study testing PF-07328948 in people with Renal Impairment and Healthy, run by Pfizer at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Healthy
- What is being tested?
- PF-07328948
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jan 2026to 13 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Orange County Research Center
Lake Forest, California, 92630
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- Recruiting
Nucleus Network
Saint Paul, Minnesota, 55114
- Recruiting
Genesis Clinical Research, LLC
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
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:
Read more
- 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.
- Conditions
- Renal Impairment, Healthy
- Being tested
- PF-07328948
- Keywords
- Healthy Volunteers, Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07328948Drug
PF-07328948 , 1 tablet orally, once on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PF-07328948 participants without renal impairment | Experimental | Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. Receives: Drug: PF-07328948 |
| Group 2: PF-07328948 participants with severe renal impairment | Experimental | Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. Receives: Drug: PF-07328948 |
| Group 3: PF-07328948 participants with moderate renal impairment | Experimental | Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. Receives: Drug: PF-07328948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).
Measured: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Unbound AUCinf (AUCinf,u) of PF-07328948
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.
Measured: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Unbound Cmax (Cmax,u) of PF-07328948
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
Measured: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Day 1 to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start28 Jan 2026
- Primary completion13 Mar 2027 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315360
- Sponsor's protocol ID
- C4921014
- Other IDs
- C4921014
- Status last verified
- May 2026
- First submitted
- 18 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
- ClinicalTrials.gov ID
- NCT07315360
- Acronym / sponsor ID
- C4921014
- Conditions
- Renal Impairment, Healthy
- Keywords
- Healthy Volunteers, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: PF-07328948 participants without renal impairment | Experimental | Drug: PF-07328948Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 2: PF-07328948 participants with severe renal impairment | Experimental | Drug: PF-07328948Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 3: PF-07328948 participants with moderate renal impairment | Experimental | Drug: PF-07328948Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07328948PF-07328948 , 1 tablet orally, once on Day 1 | Drug | Group 1: PF-07328948 participants without renal impairment, Group 2: PF-07328948 participants with severe renal impairment, Group 3: PF-07328948 participants with moderate renal impairment |
Primary outcome
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
Time frame: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).
Unbound AUCinf (AUCinf,u) of PF-07328948
Time frame: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.
Unbound Cmax (Cmax,u) of PF-07328948
Time frame: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1
Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07328948 in people with Renal Impairment and Healthy, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 (time frame: At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.