ADME: A Study to Understand What the Body does to the Study Compound Called PF-07220060 When Taken by Healthy Adults.

Prior treatment

• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• Participants whose occupation requires exposure to radiation or monitoring of radiation exposure.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to single oral dose of study intervention. • Concomitant use of any medications or substances that are strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or uridine diphosphase glucuronosyltransferase (UGT) 2B7 are prohibited within 5 half lives plus 14 days (up to 28 days) prior to the single oral dose of PF 07220060. • Use of proton-pump inhibitors is prohibited from 28 days prior to the first dosing of study intervention, and through the study. Other acid reducing agents including H2 receptor antagonists or local antacids should not be used for at least 7 days or 5 half lives, whichever is longer, before the first dosing of study intervention and are prohibited through 5 days after the dosing.
• Participants unwilling or unable to use a required concomitant medication(s).
• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
• Participants enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
• A positive urine drug test. A single repeat for positive drug screen may be allowed.

Other illness

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. Binge drinking is defined as a pattern of 5 (male) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces [240 mL] beer, 1 ounce [30 mL] of 40% spirit, or 3 ounces [90 mL] of wine).
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome [IBS] or lactose intolerance).

Lab values

• Standard 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTc corrected using Fridericia’s formula [QTcF] >450 ms, complete left bundle branch block [LBBB], signs of an acute or indeterminate- age myocardial infarction, ST segment and T wave [ST-T] interval changes suggestive of myocardial ischemia, second- or third- degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values is used to determine the participant’s eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the studyspecific laboratory and confirmed by a single repeat test, if deemed necessary: • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin ≥1.05 × upper limit of normal (ULN); participants with a history of Gilbert’s syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN; • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 based on the 2021 chronic kidney disease epidemiology (CKD-EPI) (combined serum creatinine plus serum cystatin C) equation; • Blood calcium or potassium <0.9 × lower limit of normal (LLN) or >1.1 × ULN; • Absolute neutrophil count <0.8 × LLN.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Age

• Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years, and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or 150 mm Hg (based on age) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant’s eligibility.

Other

• Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
• Use of tobacco or nicotine containing products within 3 months of screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine containing products are excluded from participation in this study).
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

• Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.