Hepatic ImpairmentPhase 1NCT07269301
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
A Phase 1 study testing PF-07328948 in people with Hepatic Impairment and Healthy, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people. Study is seeking participants who: Are between 18 and 75 years of age. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic 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
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Dec 2025to 23 Feb 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 74 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 (inclusive) and 75 years, at the screening visit.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lb).
- Group 4 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 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
- Groups 1, 2 \& 3 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening.
- Groups 1, 2 \& 3 only: stable concomitant medications for the management of individual participant's medical history.
Who cannot join
- Any condition possibly affecting drug absorption
- At screening, a positive result for HIV antibodies.
- Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
- Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Use of specific prohibited prior/concomitant therapies
- Use of an investigational product within 30 days or 5 half-lives (whichever longer).
Show all 22Show fewer
- eGFR<60 mL/min/1.73m2 at screening.
- A positive urine drug test at screening or admission to study clinic.
- At screening or admission to study clinic, a positive breath alcohol test.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
- Group 4 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.
- Group 4 only: screening ECG demonstrating QTcF interval >450 ms or a QRS interval >120 ms.
- Group 4 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
- Group 1, 2 \& 3 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year in Groups 2 \& 3 and <6 months for Group 1 only).
- Group 1, 2 \& 3 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI.
- Group 1, 2 \& 3 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.
- Group 1, 2 \& 3 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy
- Groups 1, 2 \& 3 only: severe ascites and/or pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment.
- Groups 1, 2 \& 3 only: previously received a kidney, liver, or heart transplant.
- Groups 1, 2, \& 3 only: screening ECG demonstrating a QTcF interval >470 ms or a QRS interval >120 ms.
- Groups 1, 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.
- Groups 1, 2 \& 3 only: ALT or AST >5x upper limit of normal on clinical laboratory tests at screening.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Orange County Research Center
Lake Forest, California, 92630
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- 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 AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
Study is seeking participants who:
Read more
- Are between 18 and 75 years of age.
- Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.
Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days.
During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- PF-07328948
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 4: PF-07328948 participants without hepatic impairment | Experimental | Participants without hepatic 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 moderate hepatic impairment | Experimental | Participants with moderate hepatic 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 mild hepatic impairment | Experimental | Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. Receives: Drug: PF-07328948 |
| Group 1: PF-07328948 participants with severe hepatic impairment | Experimental | Participants with severe hepatic 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, 120, and 168 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, 120, and 168 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, 120, and 168 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 posted8 Dec 2025
- Study start22 Dec 2025
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 26 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
- NCT07269301
- Sponsor's protocol ID
- C4921011
- Other IDs
- C4921011
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2025
- Last updated
- 23 Jul 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 23 Jul 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 AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT
- ClinicalTrials.gov ID
- NCT07269301
- Acronym / sponsor ID
- C4921011
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 8 Dec 2025 (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 understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
Study is seeking participants who:
- Are between 18 and 75 years of age.
- Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.
Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days.
During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 4: PF-07328948 participants without hepatic impairment | Experimental | Drug: PF-07328948Participants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 2: PF-07328948 participants with moderate hepatic impairment | Experimental | Drug: PF-07328948Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 3: PF-07328948 participants with mild hepatic impairment | Experimental | Drug: PF-07328948Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
| Group 1: PF-07328948 participants with severe hepatic impairment | Experimental | Drug: PF-07328948Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, at the screening visit.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lb).
- Group 4 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 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
Key exclusion criteria (22 listed)
- Any condition possibly affecting drug absorption
- At screening, a positive result for HIV antibodies.
- Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
- Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Use of specific prohibited prior/concomitant therapies
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 with severe hepatic impairment, Group 2: PF-07328948 participants with moderate hepatic impairment, Group 3: PF-07328948 participants with mild hepatic impairment, Group 4: PF-07328948 participants without hepatic 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, 120, and 168 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, 120, and 168 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, 120, and 168 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 23 Jul 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.
Related trials for Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement
Not yet recruitingPhase 1
Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function
Obesity, Overweight, T2DM (Type 2 Diabetes Mellitus)
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
3 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 Hepatic Impairment and Healthy, run by Pfizer at 3 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 7 inclusion and 22 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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, 120, and 168 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 23 Jul 2026.