PF-07817883 Oral Tablet Bioavailability Study in Healthy Adults to Support Treatment of COVID‑19

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What is this study about?

The study looks at how a new oral tablet containing PF-07817883 is absorbed in the blood of healthy adults. The drug is being tested in several tablet versions that contain the same amount of medicine (300 milligrams) but have different ingredients. The condition of interest is coronavirus disease 2019, although participants do not have the illness; the study uses healthy volunteers to learn how the medicine behaves in the body. The purpose of the study is to determine the oral bioavailability of the test tablets compared with a reference tablet.

In this early‑stage trial each volunteer will take one tablet after an overnight fast, then blood samples will be collected over several hours to measure how much drug reaches the bloodstream. After a short wash‑out period, the same person will receive another tablet formulation, allowing a direct comparison. The study is open‑label, meaning the participants and researchers know which tablet is being taken, and it uses a crossover design, so each person receives more than one formulation. Researchers will also watch for any side effects, check laboratory tests, vital signs, and perform a simple heart‑electric test (ECG) to ensure safety.

1 enrollment and randomization

after you agree to join the study, staff will assign you to a random order in which you will receive the different tablet formulations.

2 fasting before each dose

you will be asked not to eat or drink anything except water for at least ten hours before each dosing visit. this ensures the drug is taken under a fasted condition.

3 taking the tablet

a single 300 mg film‑coated tablet containing pf-07817883 will be given to you to swallow with water.

the tablet is taken only once during each dosing period.

4 blood sampling and monitoring

after you take the tablet, staff will draw blood at several time points to measure how much drug enters your bloodstream.

your vital signs, such as blood pressure and heart rate, will be checked, and a standard 12‑lead electrocardiogram (ecg) may be performed.

any side effects you experience will be recorded.

5 washout period

a period of time will be observed after each dose to allow the drug to leave your body before the next tablet is taken.

the length of this period will be explained by the study team.

6 repeat for each formulation

the same sequence of fasting, taking a tablet, blood sampling, and washout will be repeated for each of the test formulations and the reference formulation, following the random order assigned to you.

7 final safety assessments

after the last dosing period, additional safety checks, including laboratory tests and vital‑sign measurements, will be performed to ensure your well‑being.

the study will then be completed.

Who Can Join the Study?

Be a man or woman who is at least 18 years old (or the legal age for consent in your country) and be generally healthy, as shown by a medical check that includes your health history, a physical exam, lab tests, and an ECG (a quick heart test).
Have a body mass index (BMI) between 16 and 32 kg/m² (a measure that compares your weight to your height) and weigh more than 45 kilograms (about 99 pounds).
Be willing and able to attend all study visits, follow the treatment plan, complete lab tests, and follow any lifestyle instructions given by the study staff.
Be able to sign an informed consent form, which means you understand the study and agree to take part.

Who Cannot Join the Study?

Having a serious illness that affects the blood, kidneys, hormones, lungs, stomach or intestines, heart, liver, mind, nerves, or having drug allergies (except mild seasonal allergies) will prevent participation.
Any condition that could change how the medicine is absorbed, such as having had part of the stomach removed (gastrectomy) or the gallbladder removed (cholecystectomy), excludes you.
Having a history of, or testing positive for, HIV (human immunodeficiency virus), hepatitis B, or hepatitis C will exclude you (being vaccinated against hepatitis B is allowed).
People who work directly on the study at the research site, their family members, and employees of the study sponsor who are directly involved (and their families) cannot take part.
Any medical or mental‑health condition that could increase risk, including recent or current thoughts of suicide, abnormal lab results, or other problems that the doctor thinks make participation unsafe, will exclude you.
Testing positive for the virus that causes COVID‑19 (SARS‑CoV‑2) at the time you come in will prevent participation.
Using prescription or over‑the‑counter medicines, vitamins, or herbal supplements within the last 7 days (or for a longer time if the drug stays in the body longer) is not allowed, especially drugs that strongly affect the liver enzyme system called CYP3A. These must be stopped before the first dose.
Having taken another experimental drug or vaccine within the past 30 days (or for a longer time if the drug stays in the body longer) will exclude you.
Having high blood pressure at screening (systolic ≥ 140 mm Hg if under 60 years old, or ≥ 150 mm Hg if 60 years or older, or diastolic ≥ 90 mm Hg) will prevent participation.
Having a significant abnormal result on a standard heart test called a 12‑lead ECG (for example, a QT interval corrected by Fridericia’s formula > 450 ms, a complete left bundle branch block, signs of a recent heart attack, abnormal ST‑T changes, serious heart‑rate problems, or major conduction blocks) will exclude you.
Having certain abnormal liver blood tests at screening, such as liver enzymes (AST or ALT) more than 1.5 times the normal upper limit, or total bilirubin (a waste product processed by the liver) 1.5 times the normal upper limit, will prevent participation (except for people with Gilbert’s syndrome who have normal direct bilirubin).
Having a recent history (within the past 6 months) of alcohol abuse, binge drinking (5 or more drinks for men, 4 or more for women in about 2 hours), or using illegal drugs will exclude you.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Pfizer Clinical Research Unit	Brussels	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	13.10.2023

Trial locations

Investigated Drugs:

IBUZATRELVIR

PF-07817883 is an experimental oral medication that is being studied in a tablet form. In this trial, participants take a single dose of the tablet after fasting. The purpose of the study is to find out how much of the drug gets into the bloodstream (its bioavailability) when it is given in new tablet formulations compared with a standard reference tablet. By comparing the different versions, researchers can understand which formulation works best at delivering the medicine into the body.

Investigated Diseases:

COVID-19

COVID-19 – COVID-19 is an infectious disease caused by the SARS‑CoV‑2 virus. It typically begins with symptoms such as fever, cough, and loss of smell. The virus primarily targets cells in the nose and throat and can spread to the lungs. In many individuals the illness stays limited to the upper airway, while in others it progresses to involve the lower respiratory tract, causing pneumonia. The disease may also affect other systems, leading to fatigue, muscle aches, and gastrointestinal upset. The clinical course varies from a brief illness to a longer period of symptoms.

Trial ID:

2023-506442-24-00

Protocol code:

C5091013

Trial Phase:

Human Pharmacology (Phase I) – Other

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PF-07817883 Oral Tablet Bioavailability Study in Healthy Adults to Support Treatment of COVID‑19

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