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PF-07328948

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 6, 2026

Target and mechanism

ModalitySmall molecule

Also known as Low Dose PF-07328948

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

PF-07328948 · 7 trials · 5 indications

Phase 1 7
NCT07508228A Study to Understand How a Study Medicine Called PF-07328948 is Absorbed and Processed in the Body of Healthy Male AdultsHealthy
COMPLETED8 Analytics
NCT07455240A Study to Learn About How the Body Processes the Study Medicine Called PF-07328948 in Healthy Chinese AdultsHealthy Participant
COMPLETED10 Analytics
NCT07315360A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney FunctionRenal Impairment
RECRUITING28 Analytics
NCT07269301A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver FunctionHepatic Impairment
RECRUITING26 Analytics
NCT06837259A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy AdultsHealthy Adults
COMPLETED26 Analytics
NCT05807490A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy AdultsHealthy
COMPLETED86 Analytics
NCT05654181A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult ParticipantsHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
A Study to Understand How a Study Medicine Called PF-07328948 is Absorbed and Processed in the Body of Healthy Male Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study to Learn About How the Body Processes the Study Medicine Called PF-07328948 in Healthy Chinese Adults
Healthy ParticipantUnlock trial analytics
PHASE1RECRUITING
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Renal ImpairmentUnlock trial analytics
PHASE1RECRUITING
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
Hepatic ImpairmentUnlock trial analytics
PHASE1COMPLETED
A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults
Healthy AdultsUnlock trial analytics
PHASE1COMPLETED
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered.
Period 1 pre-dose to maximum Days 22
Maximum Observed Plasma Concentration (Cmax)
Day 1, 7
Area under the plasma concentration (AUC)
Day 1, 7
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
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
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
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.

Maximum Observed Plasma Concentration (Cmax) of PF-07328948
Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07328948
Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose

if data permits

Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07328948
Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose

If AUCinf cannot be completed

Part A: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Part A: Number of Participants With Clinical Laboratory Abnormalities
Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).
Part A: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Change From Baseline in Physical Examination Findings
Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
0 to 8 hours post-dose on Day 1
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-07328948 Tablet Formation and Oral Suspension
Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07328948 Tablet Formation and Oral Suspension
Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to Extrapolated Infinite Time (AUCinf) of PF-07328948 Tablet Formation and Oral Suspension
Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes \<0.8 x lower limit of normal (LLN) or \>1.2 x upper limit of normal (ULN); Neutrophils \<0.8 x LLN; Neutrophils/Leukocytes \<0.8 x LLN; Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; Bilirubin \>1.5 x ULN; Indirect Bilirubin \>1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) \>20.

Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.

Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline

Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate)
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

Maximum increase from baseline in ECG Mean Heart Rate was reported.

Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Day 1-8 per period, along with the 28-35 day post-final dose follow-up

Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported.

Secondary Endpoints

Number of Participants with Treatment Emergent Adverse Events
From baseline and through 28 to 35 days post last study intervention dose
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Day 1 to Day 36
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline (Day 0) up to 35 days after last dose of study medication
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1/Treatment AEXPERIMENTALParticipants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension.
Period 3/Treatment CEXPERIMENTALParticipants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
Period 4/Treatment DEXPERIMENTALParticipants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets
Period 2/Treatment BEXPERIMENTALParticipants will receive a single tablet of unlabeled oral dose of PF-07328948; \~ 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948
Arm 1EXPERIMENTALParticipants will receive oral daily PF-07328948 tablet for 7 consecutive days.
Group 1: PF-07328948 participants without renal impairmentEXPERIMENTALParticipants 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 impairmentEXPERIMENTALParticipants 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 impairmentEXPERIMENTALParticipants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Group 4: PF-07328948 participants without hepatic impairmentEXPERIMENTALParticipants 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 impairmentEXPERIMENTALParticipants 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 impairmentEXPERIMENTALParticipants 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 impairmentEXPERIMENTALParticipants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Period 1EXPERIMENTALPF-07328948
Period 2EXPERIMENTALcyclosporine and PF-07328948
Period 3 (optional)EXPERIMENTALclarithromycin and PF-07328948
PF-07328948 and Placebo (Cohort 1)EXPERIMENTALDose level 1: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 2)EXPERIMENTALDose level 2: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 3)EXPERIMENTALDose level 3: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 4)EXPERIMENTALDose level 4: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 5)EXPERIMENTALDose level 5: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 10)EXPERIMENTALOptional cohort - Multiple dose administration of PF-07328948 and placebo over 14 days in healthy Japanese participants; 5 participants will receive PF-07328948 and 1 will receive placebo
PF-07328948 and Placebo (Cohort 7)EXPERIMENTALDose level 7: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 8)EXPERIMENTALOptional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 oral tablet and oral suspension (Cohort 11)EXPERIMENTALAssessment of relative bioavailability PF-07328948 oral tablet compared to PF-07328948 oral suspension under fed and fasted condition; 12 participants will be enrolled, and 6 participants randomized to 1 of 2 sequences
PF-07328948 and Placebo (Cohort 6)EXPERIMENTALDose level 6: Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
PF-07328948 and Placebo (Cohort 9)EXPERIMENTALOptional cohort - Dose level TBD. Multiple dose administration of PF-07328948 and placebo over 14 days in healthy participants; 8 participants will receive PF-07328948 and 2 will receive placebo
Cohort 1EXPERIMENTALParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Cohort 2EXPERIMENTALParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.
Cohort 3EXPERIMENTALParticipants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined.

Interventions

NameTypeDescription
Oral [14C]PF-07328948DRUGA single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)
Oral Unlabeled PF-07328948DRUGA single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion)
IV [14C]PF-07328948DRUGA single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 administered as tablets.
PF-07328948DRUGOral tablet
cyclosporineDRUG600 mg capsule day 12 (Part A)
clarithromycinDRUG500 mg tablets twice daily day 1 to day 6 (Part B)
PlaceboDRUGPlacebo will be administered as oral suspensions BID over 14 days
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Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Male participants aged ≥18 years to \<65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 17.5-32 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Crit...

Countries:United StatesChinaBelgium
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Recent Changes (Last 90 Days)

MEDIUMSep 6, 2026NCT07508228TRIAL_REMOVED: changed
MEDIUMSep 6, 2026NCT07508228TRIAL_REMOVED: changed
MEDIUMSep 6, 2026NCT07508228TRIAL_REMOVED: changed
HIGHAug 6, 2026NCT07508228Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 6, 2026NCT07508228Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJul 24, 2026NCT07269301lastUpdatePostDate: changed
LOWJul 24, 2026NCT07269301lastUpdatePostDate: changed
MEDIUMJul 20, 2026NCT07508228Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 20, 2026NCT07508228Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about PF-07328948

What is Low Dose PF-07328948 used for?

Low Dose PF-07328948 is an investigational small molecule being developed by Pfizer for cardiovascular conditions, specifically heart failure. It is currently in Phase 2 clinical trials for heart failure, with additional Phase 1 studies in healthy adults and in people with hepatic or renal impairment.

Who makes Low Dose PF-07328948?

Low Dose PF-07328948 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting multiple clinical trials to evaluate the drug in various populations, including healthy adults and patients with heart failure.

What phase is Low Dose PF-07328948 in?

Low Dose PF-07328948 is in Phase 2 clinical development for heart failure, as shown by the recruiting BRANCH-HF trial. It is also being studied in Phase 1 trials for hepatic and renal impairment. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Low Dose PF-07328948 in?

Low Dose PF-07328948 is being studied in several trials. NCT06991257 is a Phase 2 study in adults with heart failure. NCT06837259 is a completed Phase 1 drug interaction study in healthy adults. NCT07269301 and NCT07315360 are Phase 1 studies in hepatic and renal impairment, respectively.

Is Low Dose PF-07328948 the same as PF-07328948?

Yes, Low Dose PF-07328948 is the same as PF-07328948. The drug is referred to by both names in clinical trial records, with PF-07328948 being the primary identifier used in study titles and descriptions.

Is Low Dose PF-07328948 FDA approved?

Low Dose PF-07328948 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for heart failure and Phase 1 trials for other conditions. Approval status has not been granted, and the drug remains in clinical development.