Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.

Pfizer

Status and phase

Withdrawn

Phase 1

Conditions

Healthy Participants

Treatments

Drug: [14C]PF-07321332

Study type

Interventional

Funder types

Industry

Identifiers

NCT05178654

C4671007

Details and patient eligibility

About

This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled [14C]PF-07321332 in healthy male participants following oral administration with ritonavir.

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion criteria

Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
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).
Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
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 B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
A positive urine drug test.
Participants enrolled in a previous radio-nucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rems per year).