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Study of PF-07220060 Oral and IV Forms in Healthy Adult Men to Assess How the Body Processes the Drug for Metastatic Breast Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study looks at a medicine called PF-07220060, which is being developed for the treatment of metastatic/advanced breast cancer. The goal is to understand how the body takes in the drug, moves it around, changes it, and gets rid of it. This information helps researchers know whether the drug might work well for patients with the disease.

In the trial, healthy adult men receive a single dose of the medicine either as an oral suspension that is swallowed or as an intravenous infusion that is given through a vein. The drug is labeled with a small amount of radioactive material using a 14C-microtracer technique, which allows scientists to track the medicine without affecting how it works. Over several days, urine and stool are collected and blood samples are taken to measure how much of the drug and its breakdown products are present. By comparing the amounts after the oral dose and the infusion, the study can calculate the absolute bioavailability and the fraction absorbed, which tell how much of the medicine actually reaches the bloodstream. Safety checks such as physical exams, lab tests, and heart monitoring are also performed throughout the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Check‑In and Confirmation of Consent

    You arrive at the study site and confirm that you have given informed consent to take part in the trial.

    Study staff verify your identity and ensure that all required paperwork is complete before any procedures begin.

  2. Step 2

    Baseline Health Assessments

    A physical examination is performed to record your overall health status.

    Vital signs such as blood pressure, heart rate, breathing rate, and temperature are measured.

    A 12‑lead ECG (electrocardiogram) records the electrical activity of your heart.

    Blood and urine samples are collected for laboratory tests that serve as a reference for later comparison.

  3. Step 3

    Administration of the Study Medication

    You receive a single dose of the study drug PF‑07220060 according to the group to which you have been assigned.

    If you are in the oral group, you take one 100 mg (milligram) dose of an oral suspension by mouth. The dose is taken once and no additional doses are given.

    If you are in the intravenous group, you receive one 100 µg (microgram) dose of a solution for intravenous infusion. The medication is delivered through a vein by a trained professional, typically over a short period of time.

  4. Step 4

    Post‑Dose Monitoring

    After the medication is given, you remain at the clinic for a monitoring period during which staff check your vital signs and watch for any immediate side effects.

    Additional ECG recordings may be taken to ensure your heart rhythm remains normal.

    If any adverse symptoms appear, they are documented and managed according to the study protocol.

  5. Step 5

    Collection of Urine and Feces Samples

    You are asked to collect all urine and feces you produce for a defined period, usually up to several days after dosing.

    These samples are used to determine how much of the radioactive label attached to PF‑07220060 is excreted, which helps assess the drug’s absorption and elimination.

    Staff provide containers and instructions to ensure the samples are collected safely and stored correctly.

  6. Step 6

    Scheduled Follow‑Up Visits

    You return to the clinic on predetermined days (for example, on days 2, 4, and 7 after dosing) for additional health checks.

    During each visit, vital signs are measured, a brief physical exam is performed, and any new symptoms are recorded.

    Further blood, urine, or feces samples may be taken to complete the pharmacokinetic and safety evaluations.

  7. Step 7

    Final Assessment and Study Completion

    At the end of the sampling period, a final physical examination, vital‑sign check, and ECG are performed.

    The last set of laboratory tests is done to confirm that no delayed adverse effects have occurred.

    After all assessments are completed and the study data are collected, you are discharged from the trial.

Who can join the trial?

4 criteria

  • Male participants who are between 18 and 65 years old and are considered healthy after a medical check that includes review of medical history, a physical exam, lab tests, and heart monitoring.
  • Must have a Body mass index (BMI) between 17.5 and 30.5 kg/m² (BMI is a simple calculation that compares weight to height) and weigh more than 50 kg (110 lb).
  • Must provide a signed and dated informed consent document (ICD) (a form showing you understand the study and agree to take part).
  • Must be willing and able to follow all scheduled visits, take the study medication as directed, complete required lab tests, and follow any lifestyle instructions given by the study team.

Who cannot join the trial?

25 criteria

  • Having a significant disease of the blood, kidneys, hormones, lungs, stomach/intestines, heart, liver, mental health, nerves, or any serious allergy (except mild seasonal allergies) excludes you.
  • Any condition that could change how the medicine is absorbed, such as having had your stomach removed (gastrectomy) or gallbladder removed (cholecystectomy), excludes you.
  • A past or present infection with HIV, hepatitis B, or hepatitis C, or a positive test for these infections excludes you (vaccination for hepatitis B is allowed).
  • An abnormal ECG (heart tracing) showing any of the following excludes you: QTcF (a measure of heart’s electrical recovery time) longer than 450 ms, a complete left bundle branch block, signs of a recent or uncertain‑age heart attack, ST‑T changes suggesting poor heart blood flow, second‑ or third‑degree atrioventricular block, serious slow or fast heart rhythms, or a QRS width greater than 120 ms.
  • Having a level of total radioactivity in your blood plasma higher than 11 mBq/mL excludes you.
  • Abnormal lab test results at screening exclude you, including:
    • Liver enzymes ALT or AST or bilirubin (a substance made by the liver) that are 1.05 times higher than the normal upper limit.
    • Kidney function measured as eGFR (estimated glomerular filtration rate) less than 60 mL/min/1.73 m².
    • Blood calcium or potassium that is lower than 0.9 times the normal lower limit or higher than 1.1 times the normal upper limit.
    • An absolute neutrophil count (a type of white blood cell) lower than 0.8 times the normal lower limit.
    • History of alcohol abuse, binge drinking, or illegal drug use within the past 6 months excludes you. Binge drinking means 5 or more drinks for men in about 2 hours; overall alcohol should not exceed 14 units per week.
    • Use of tobacco or any nicotine‑containing product within the past 3 months, or a positive urine test for nicotine (cotinine), excludes you.
    • Donating about 1 pint (500 mL) or more of blood (excluding plasma) within 60 days before the study dose excludes you.
    • Having a known sensitivity to heparin or a reaction called heparin‑induced low platelets excludes you.
    • Working in a job that requires exposure to radiation or monitoring of radiation exposure excludes you.
    • Being a study staff member, a family member of study staff, or a sponsor employee directly involved in the study (or their families) excludes you.
    • Having a history of irregular bowel movements such as frequent diarrhea, constipation, irritable bowel syndrome (IBS), or lactose intolerance excludes you.
    • Any medical or psychiatric condition that could increase risk, including recent (within the past year) or active thoughts of suicide, excludes you.
    • Using prescription or over‑the‑counter medicines, dietary supplements, or herbal products within 7 days (or 5 half‑lives, whichever is longer) before the study dose excludes you. This also includes:
      • Strong inducers or inhibitors of the enzymes CYP3A4 or UGT2B7 within up to 28 days before dosing.
      • Proton‑pump inhibitors (medicines that reduce stomach acid) within 28 days before dosing and during the study.
      • Other acid‑reducing medicines (H2 blockers or antacids) within 7 days (or 5 half‑lives) before dosing and for 5 days after dosing.
      • If you are unwilling or unable to take a required additional medication, you cannot participate.
      • Having taken another investigational drug or vaccine within 30 days (or 5 half‑lives) before the study dose, or having previously taken the study drug itself, excludes you.
      • Participation in a previous radionucleotide study or having received radiotherapy within the past 12 months that would cause excess radioactivity excludes you.
      • A positive urine drug test (a repeat test may be allowed) excludes you.
      • High blood pressure at screening excludes you: systolic (top number) 140 mm Hg or higher (or 150 mm Hg for people 60 years or older) or diastolic (bottom number) 90 mm Hg or higher after at least 5 minutes of lying down, with repeat measurements required.
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Investigated drugs

PF-07220060 oral suspension
This is a liquid form of the investigational drug PF-07220060 that participants swallow. In the study it is given as a single dose to healthy adult men. The purpose of this medication is to see how the drug is absorbed from the gut into the bloodstream, how it spreads through the body, and how it is broken down and removed. By measuring these processes, researchers can learn how much of the drug actually becomes available to work in the body (its absolute bioavailability) and what fraction of the dose is absorbed. [14C] PF-07220060 IV solution
This version of PF-07220060 contains a tiny amount of a radioactive carbon label ([14C]) and is delivered directly into a vein through an infusion. The radioactive label allows scientists to track the drug and its breakdown products very precisely as they move through the body and are excreted. The IV route provides a way to compare how the drug behaves when given directly into the bloodstream versus when taken by mouth. [14C] PF-07220060 oral suspension
This is the same liquid form of PF-07220060 taken by mouth, but it also includes the [14C] radioactive label. Giving the labeled drug orally lets researchers follow the exact path of the drug after it is swallowed, measuring how much reaches the bloodstream, how it is metabolized, and how it is eliminated. Comparing the results from this oral labeled version with the IV labeled version helps determine the drug’s absolute bioavailability and the fraction of the dose that is absorbed.

What is already known about the treatment

PF-07220060 - The drug is provided as an oral suspension that is swallowed or as a solution for intravenous infusion that is given through a vein, allowing it to reach the body either via the gut or directly into the bloodstream. It is still an experimental medicine being studied in early‑phase trials, with no approved use yet, and is being investigated mainly for metastatic or advanced breast cancer. The compound works by blocking a specific protein that helps cancer cells grow and spread, thereby stopping the signal that tells the cells to multiply. It is classified as a targeted anticancer agent, specifically a kinase inhibitor.

Investigated diseases

Metastatic breast cancer - Metastatic breast cancer is a form of breast cancer that has spread from the original tumor in the breast to other parts of the body. Cancer cells travel through the bloodstream or lymphatic system and form new tumors in distant organs such as bone, lung, liver, or brain. The disease progresses as these secondary tumors grow and may cause new symptoms depending on their location. Over time, the number and size of metastatic sites can increase, reflecting ongoing spread of the disease.
Trial detailsLast updated 27 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507074-40-00Protocol codeC4391010Estimated enrolment12 patientsSponsorPfizer Inc.

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