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Safety, Tolerability and Pharmacokinetics of Oral PF-07293893 in Healthy Adults for Future Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on a condition called heart failure with preserved ejection fraction, a form of heart failure where the heart’s pumping ability is normal but it does not relax properly, leading to symptoms such as shortness of breath and fatigue. The investigational medicine being tested is identified as PF-07293893, an oral suspension given in increasing single doses. A matching inactive substance, referred to as placebo, is also used for comparison. The main aim of the trial is to learn whether the medicine is safe, how well participants tolerate it, and to understand its pharmacokinetics, which means how the drug is absorbed, distributed, and cleared from the body.

Participants are healthy adults who will receive one dose of the study medicine or the placebo, then after a short break will receive another dose at a higher level. During each visit, researchers will check vital signs, perform blood tests, and monitor heart activity using continuous monitoring and a simple heart test called electrocardiograms. They will also ask about any unwanted effects and perform basic physical and neurological checks. The study follows a schedule of several visits over a few weeks to collect all needed information.

The research process

The trial runs in 15 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and dosing schedule
After you join the study, you will be assigned a random order in which you will receive three different treatments and one placebo. the order is decided by the study team and you will not know which treatment you receive at each visit.
Step 2
First dose administration
You will attend the clinic and be given a single oral dose. the dose may be pf-07293893 at 500 mg, pf-07293893 at 1500 mg, or a matching placebo. the medication is provided as an oral suspension, which is a liquid that you swallow. the dose is taken once, with water, on the day of the visit.
Step 3
Immediate safety monitoring after the first dose
Shortly after taking the dose, study staff will check your vital signs (blood pressure, heart rate, temperature). you will have a continuous heart rhythm monitor and a 12‑lead electrocardiogram (ecg) to record heart activity. a physical examination and basic laboratory tests (blood and urine) will also be performed to look for any immediate reactions.
Step 4
Follow‑up safety assessments after the first dose
You will return to the clinic for additional check‑ups over the next few days. these visits include repeat vital sign measurements, another ecg, and repeat laboratory tests to see how your body is responding as the medication is processed.
Step 5
Washout period before the second dose
Before the next dosing visit, you will wait a period of time that allows the previous dose to leave your body. this interval, called a washout period, ensures that the next dose can be evaluated without interference from the earlier one.
Step 6
Second dose administration
You will receive the next assigned treatment, which again will be a single oral dose of either pf-07293893 (500 mg or 1500 mg) or the matching placebo, taken as an oral suspension with water.
Step 7
Safety monitoring after the second dose
The same set of immediate checks performed after the first dose—vital signs, continuous heart monitoring, ecg, physical exam, and laboratory tests—will be repeated right after you take the second dose.
Step 8
Follow‑up assessments after the second dose
You will attend scheduled follow‑up visits for several days after the second dose, during which the study team will repeat vital sign checks, ecg recordings, and laboratory tests to monitor your response.
Step 9
Washout period before the third dose
Another washout period will be observed to clear the previous dose from your system before the next dosing visit.
Step 10
Third dose administration
You will take the third assigned treatment, again a single oral dose of either pf-07293893 (500 mg or 1500 mg) or the matching placebo, administered as an oral suspension.
Step 11
Safety monitoring after the third dose
Immediate safety checks—vital signs, heart rhythm monitoring, ecg, physical examination, and laboratory testing—will be performed right after the third dose.
Step 12
Follow‑up assessments after the third dose
You will continue to attend follow‑up visits for a few days, during which the same safety measurements will be repeated.
Step 13
Washout period before the fourth dose
A final washout period will be observed to ensure the previous dose is fully cleared before the last dosing visit.
Step 14
Fourth dose administration
You will receive the last assigned treatment, which will be a single oral dose of either pf-07293893 (500 mg or 1500 mg) or the matching placebo, taken as an oral suspension.
Step 15
Final safety monitoring and study completion
After the fourth dose, the study team will conduct the final round of immediate safety checks (vital signs, heart monitoring, ecg, physical exam, laboratory tests) and schedule any remaining follow‑up visits needed to complete the safety evaluation. once these assessments are finished, your participation in the study is considered complete.

Who can join the trial?

2 criteria

Be a man aged 18‑65 years or a woman who cannot become pregnant, and be willing to sign the informed consent document (a paper that shows you agree to join the study); you must be in good overall health as shown by a doctor’s review of your medical history (your past illnesses), a physical check‑up (a hands‑on exam), laboratory tests (blood or urine tests), and heart monitoring (checking how your heart works).
Have a body mass index (BMI) between 16 and 30.5 (BMI is a number that compares your weight to your height) and weigh more than 50 kg (about 110 lb).

Who cannot join the trial?

12 criteria

Having a significant disease of the blood, kidneys, hormones, lungs, digestive system, heart, liver, mind, nerves, or allergies (except mild seasonal allergies without symptoms at the time of dosing). Hematological means blood, renal means kidney, endocrine means hormone, pulmonary means lung, gastrointestinal means digestive, cardiovascular means heart, hepatic means liver, psychiatric means mental health, neurological means nerve.
Any condition that could change how the drug is absorbed, such as having had part of the stomach removed (gastrectomy) or the gallbladder removed (cholecystectomy).
History of infection with HIV (the virus that can cause AIDS), hepatitis B, or hepatitis C, or a positive test for these infections (including hepatitis B surface antigen or hepatitis C antibody). Vaccination for hepatitis B is allowed.
Being a staff member who works directly on the study, a family member of such staff, or an employee of the sponsor who is directly involved in the study, or their family members.
Any medical or mental‑health condition that could increase risk, including recent (within the past year) or active thoughts of suicide, abnormal lab results, or any situation related to COVID‑19 that the investigator thinks makes participation unsafe.
Using prescription medicines, over‑the‑counter drugs, dietary supplements, or herbal products within 7 days (or 5 drug half‑lives, whichever is longer) before the first dose, except for certain strong enzyme‑affecting drugs (CYP3A inducers or inhibitors) which must be stopped at least 14 days plus 5 half‑lives before dosing.
Having received any investigational drug or vaccine within the past 30 days (or as required locally) before the first dose, or being enrolled in another investigational study at any time during this trial.
Blood pressure measured while lying down (supine) that is 140 mm Hg systolic or higher, or 90 mm Hg diastolic or higher, for participants under 60 years old; or 150 mm Hg systolic or higher, or 90 mm Hg diastolic or higher, for participants 60 years or older, after at least 5 minutes of rest.
Kidney function measured as an estimated glomerular filtration rate (eGFR) less than 75 mL/min/1.73 m².
Results from a standard 12‑lead electrocardiogram (ECG) that show serious heart rhythm or conduction problems, such as a QTcF interval longer than 450 ms, left bundle branch block, signs of a recent heart attack, ST‑T changes suggesting reduced blood flow to the heart, second‑ or third‑degree atrioventricular block, or dangerous slow (bradyarrhythmia) or fast (tachyarrhythmia) heart rhythms.
Abnormal laboratory test results at screening, such as high liver enzymes (ALT, AST) or total bilirubin that is 1.05 times or more the normal upper limit, unless explained by a harmless condition like Gilbert’s syndrome with normal direct bilirubin.
History of alcohol abuse or binge drinking, or use of illegal drugs or dependence on them within the past 6 months. Binge drinking is defined as 5 or more drinks for men, or 4 or more drinks for women, consumed in about 2 hours; overall alcohol intake should not exceed 14 units per week (1 unit = 12 oz beer, 1 oz of 40% spirit, or 3 oz of wine).

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Investigated drugs

PF-07293893 DPI
is an experimental oral medication given as a liquid suspension. In this study participants swallow the suspension to see how the drug is absorbed and how the body handles it. The purpose is to check whether a single dose is safe, how well participants tolerate it, and to learn basic information about how the drug moves through the body.
PF-07293893 crystalline
is another form of the same experimental drug, also taken by mouth as a liquid suspension. This version uses a crystalline preparation of the compound. The study uses this form to compare its safety and how the body processes it with the other formulations.
PF-07293893
is the core investigational compound being tested. It is administered as an oral suspension in a single dose. The trial examines this drug to determine if it can be given safely to healthy adults, how well participants tolerate it, and to gather early information on its pharmacokinetic behavior (how quickly it is absorbed, distributed, metabolized, and eliminated).

What is already known about the treatment

PF-07293893 - It is taken as an oral suspension that participants swallow, with study doses of 500 mg or 1500 mg. The drug is still investigational and is being tested for the first time in humans, so it is not yet approved for any use. It is being studied for treating heart failure with preserved ejection fraction, a condition where the heart pumps normally but does not relax well. The compound works by blocking a protein that makes heart muscle stiff, helping the heart relax more easily, and it belongs to the class of experimental small‑molecule cardiac drugs.

Investigated diseases

heart failure with preserved ejection fraction (HFpEF) - a condition in which the heart’s left ventricle becomes stiff and cannot relax properly, causing fluid to build up in the lungs and other tissues despite a normal ejection fraction. Patients often experience shortness of breath, fatigue, and swelling in the legs during everyday activities. Over time the ventricles become thicker and less compliant, making it harder for the heart to fill with blood. This leads to a gradual increase in symptoms as the disease progresses.