Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of PF 07304814 administered at a dose of 500 mg [14C] PF-07304814 containing approximately 420 nCi [14C] PF-07304814 as a constant-rate, continuous IV infusion over 24 hours

Official Title
-----------------
A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO INVESTIGATE THE MASS BALANCE, METABOLISM AND EXCRETION OF [14C]-PF-07304814 IN HEALTHY PARTICIPANTS USING A 14C-MICROTRACER APPROACH

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PF-07304814


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. BMI of 18 to 32 kg/m2; and a total body weight >50 kg (110 lb). Exclusion Criteria: 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). Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1. 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. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participants who have received a COVID-19 vaccine within the past 2 weeks; and/or participants who are scheduled to receive a second COVID-19 vaccination dose during the in-clinical period of this study. A positive urine drug test. Total 14C radioactivity measured in plasma exceeding 11 mBq/mL at Screening . Females who are breastfeeding. History of tobacco or nicotine use within 3 months prior to dosing, or a positive cotinine at screening or Day -1. 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 (ie, occupational exposure of 5 rem per year). 13. Participants whose occupation requires exposure to radiation or monitoring of radiation exposure. 14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07304814<br>PF-07304814 is an anti-viral, formulated for intravenous delivery | Drug: PF-07304814<br>* PF-07304814 is an anti-viral, formulated for intravenous delivery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered. | To characterize the extent of excretion of total radioactivity in urine and feces following administration of 24 hour single intravenous infusion of radiolabeled PF-07304814 | Predose to maximum of Day 10 | 
| AUClast of intravenous radiolabeled PF-07304814 in plasma | Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-07304814 following intravenous infusion of radiolabeled PF-07304814 . | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| Cmax of intravenous radiolabeled PF-07304814 in plasma | Maximum plasma concentration of radiolabeled PF-07304814 following intravenous infusion of radiolabeled PF-07304814 . | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| Tmax of intravenous radiolabeled PF-07304814 in plasma | Time to Cmax following intravenous infusion of radiolabeled PF-07304814 | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| AUCinf of intravenous radiolabeled PF-07304814 in plasma (if data permit) | Area under the plasma concentration-time profile from time zero extrapolated to infinite time following intravenous infusion of radiolabeled PF-07304814 . | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| t1/2 of intravenous radiolabeled PF-07304814 in plasma (if data permit) | Terminal elimination half-life following intravenous infusion of radiolabeled PF-07304814 | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| CL of intravenous radiolabeled PF-07304814 in plasma (if data permit) | Systemic clearance following intravenous infusion of radiolabeled PF-07304814. | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| Vss of intravenous radiolabeled PF-07304814 in plasma (if data permit) | Steady-state volume of distribution following intravenous infusion of radiolabeled PF-07304814. | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| Obsereved plasma concentration at 24 hours | Plasma concentration at 24hour following intravenous infusion of radiolabeled PF-07304814 . | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 
| Total radioactivity in plasma and pharmacokinetics of PF-00835231 and PF-07304814 | To characterize total radioactivity (PF-07304814 and PF-00835231) in plasma following administration of 24 hour single intravenous infusion of radiolabeled PF-07304814 | Pre-dose, 0.5, 1,2, 6, 12, 24, 25, 27, 32, 48, 72, 96, 120, 144 and 216 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and determination of relative abundance of the metabolites of PF-07304814 in plasma, urine, and feces | To identify metabolites of PF 07304814 in plasma, urine and feces, if possible | Predose to maximum of Day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Viral Disease