HealthyPhase 1NCT05050682

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

A Phase 1 study testing PF-07304814 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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]… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-07304814
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2021to 10 Dec 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fortrea Clinical Research Unit - Madison
Madison, Wisconsin, 53704

Other trials in United States

About this study

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
Being tested: PF-07304814
Keywords: COVID-19, SARS-COV-2, Viral Disease
Medical subject headings: COVID-19, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07304814Drug
PF-07304814 is an anti-viral, formulated for intravenous delivery

Study groups in NCT05050682
Study group	Role	What they receive
PF-07304814	Experimental	PF-07304814 is an anti-viral, formulated for intravenous delivery Receives: Drug: PF-07304814

What is being measured

The primary outcome is the main question the study is designed to answer.

The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
Measured: from pre-dose to 216h post the start of infusion
The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
Measured: from pre-dose to 216h post the start of infusion
The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
Measured: from pre-dose to 216h post the start of infusion
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma PF-07304814 and Plasma PF-00835231
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231
Area under the concentration-time profile from time zero extrapolated to infinite time. AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis (if data permit).
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
AUCinf for Plasma Total [14C]
Area under the concentration-time profile from time zero extrapolated to infinite time. AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis (if data permit).
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231
Maximum observed plasma concentration. This was observed directly from data.
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Cmax for Plasma Total [14C]
Maximum observed plasma concentration. This was observed directly from data.
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Time for Cmax (Tmax) for Plasma PF-07304814 and Plasma PF-00835231
Time for Cmax. This was observed directly from data as time of first occurrence.
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Tmax for Plasma Total 14C
Time for Cmax. This was observed directly from data as time of first occurrence.
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Obsereved Plasma Concentration at 24 Hours (C24) for Plasma PF-07304814 and Plasma PF-00835231
Obsereved plasma concentration at 24 hours. This was observed directly from data.
Measured: 24 hours post the start of infusion
C24 for Plasma Total [14C]
Obsereved plasma concentration at 24 hours. This was observed directly from data.
Measured: 24hours post the start of infusion
Systematic Clearance (CL) for Plasma PF-07304814
Systemic clearance. This was determined by Dose/AUCinf (if data permit).
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Steady-state Volume of Distribution Following Intravenous Infusion (Vss) for Plasma PF-07304814
Steady-state volume of distribution following intravenous infusion. This was determined by Vss=CL × [MRT-(infusion time/2)] where MRT is the Mean Residence Time and is calculated as AUMCinf (the area under the first moment curve from time 0 extrapolated to infinite time)/AUCinf (area under the concentration-time profile from time 0 extrapolated to infinite time), if data permit.
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Terminal Elimination Half-life (t½) for Plasma PF-00835231
Terminal elimination half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve (if data permit).
Measured: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
t½ for Plasma Total [14C]
Terminal elimination half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve (if data permit).
Measured: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Secondary outcomes (5)

Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814
The percentage of radioactivity collected over the time frame for each metabolite was determined and reported as percentage of total radioactivity in each matrix (plasma, urine and feces).
Measured: Predose to maximum of Day 10
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Treatment-Emergent Adverse Event if the event started during the effective duration of treatment. All events that start on or after the first dosing day and time/ start time, if collected, but before the last dose plus the lag time (28 days) will be flagged as TEAEs. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent or significant disability/incapacity, 5. was a congenital anomaly/birth defect, 6. was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, is considered serious, and other situations defined in the protocol
Measured: From first dose up to 28-35 days from administration of the dose of study intervention (maximum of 35 days)
Number of Subjects With Vital Signs Data Meeting Categorical Summarization Criteria
The following abnormality criteria were applied: diastolic blood pressure: value < 50 mmHg, change >=20 mmHg increase/decrease; systolic blood pressure: value < 90 mmHg, change >= 30 mmHg increase/decrease; pulse rate: value< 40 beats per minute, value > 120 beats per minute.
Measured: from Screening (Day-42 to Day-2) to 216h or early termination/discontinuation
Number of Subjects With Laboratory Test Abnormalities (Without Regards to Baseline Abnormality)
Safety laboratory assessments including urinalysis, hematology, and chemistry were performed at the indicated time-points. All the safety laboratory samples must be collected following at least a 4 hour fast.
Measured: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation
Number of Subjects With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
ECG endpoints meeting the criteria of potential clinical concern were summarized by treatment using categories as defined:PR interval (msec): value >280, %change >= 25%, %change >= 50%; QRS complex (msec): value > 120; QT interval (msec): value > 500; QTcF (msec): 450 < value <=480, 480 <value <= 500, 30 <= increase <= 60, increase >60.
Measured: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202110 Dec 2021

First posted20 Sep 2021
Study start7 Oct 2021
Primary completion10 Dec 2021
Study completion10 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05050682
Sponsor's protocol ID: C4611003
Other IDs: NCT05050682
Status last verified: Oct 2025
First submitted: 10 Sep 2021
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05050682
Acronym / sponsor ID: C4611003
Conditions: Healthy
Keywords: COVID-19, SARS-COV-2, Viral Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 7 Oct 2021 (actual)
Primary completion: 10 Dec 2021 (actual)
Study completion: 10 Dec 2021 (actual)
First posted: 20 Sep 2021 (actual)
Results: Posted 23 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-07304814	Experimental	Drug: PF-07304814PF-07304814 is an anti-viral, formulated for intravenous delivery

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07304814PF-07304814 is an anti-viral, formulated for intravenous delivery	Drug	PF-07304814

Primary outcome

The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered
Time frame: from pre-dose to 216h post the start of infusion
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered
Time frame: from pre-dose to 216h post the start of infusion
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)
Time frame: from pre-dose to 216h post the start of infusion
This is to confirm mass balance and characterize the routes of elimination of [14C]-PF-07304814 and drug related materials following 420 nCi/500 mg dose of [14C] PF-07304814.
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma PF-07304814 and Plasma PF-00835231
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.
Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area under the concentration-time profile from time zero extrapolated to infinite time. AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis (if data permit).
AUCinf for Plasma Total [14C]
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Area under the concentration-time profile from time zero extrapolated to infinite time. AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis (if data permit).
Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Maximum observed plasma concentration. This was observed directly from data.
Cmax for Plasma Total [14C]
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Maximum observed plasma concentration. This was observed directly from data.
Time for Cmax (Tmax) for Plasma PF-07304814 and Plasma PF-00835231
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Time for Cmax. This was observed directly from data as time of first occurrence.
Tmax for Plasma Total 14C
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Time for Cmax. This was observed directly from data as time of first occurrence.
Obsereved Plasma Concentration at 24 Hours (C24) for Plasma PF-07304814 and Plasma PF-00835231
Time frame: 24 hours post the start of infusion
Obsereved plasma concentration at 24 hours. This was observed directly from data.
C24 for Plasma Total [14C]
Time frame: 24hours post the start of infusion
Obsereved plasma concentration at 24 hours. This was observed directly from data.
Systematic Clearance (CL) for Plasma PF-07304814
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Systemic clearance. This was determined by Dose/AUCinf (if data permit).
Steady-state Volume of Distribution Following Intravenous Infusion (Vss) for Plasma PF-07304814
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Steady-state volume of distribution following intravenous infusion. This was determined by Vss=CL × [MRT-(infusion time/2)] where MRT is the Mean Residence Time and is calculated as AUMCinf (the area under the first moment curve from time 0 extrapolated to infinite time)/AUCinf (area under the concentration-time profile from time 0 extrapolated to infinite time), if data permit.
Terminal Elimination Half-life (t½) for Plasma PF-00835231
Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Terminal elimination half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve (if data permit).
t½ for Plasma Total [14C]
Time frame: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion
Terminal elimination half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve (if data permit).

5 secondary outcomes

Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814
Time frame: Predose to maximum of Day 10
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose up to 28-35 days from administration of the dose of study intervention (maximum of 35 days)
Number of Subjects With Vital Signs Data Meeting Categorical Summarization Criteria
Time frame: from Screening (Day-42 to Day-2) to 216h or early termination/discontinuation
Number of Subjects With Laboratory Test Abnormalities (Without Regards to Baseline Abnormality)
Time frame: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation
Number of Subjects With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
Time frame: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation

Results and safety

Results posted to the registry on 23 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
14C-PF-07304814 500 mg IV	5	5

Primary outcome: The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered

Time frame: from pre-dose to 216h post the start of infusion. Mean (Standard Deviation). Unit: percentage of dose

Measure	14C-PF-07304814 500 mg IV n = 5
Value	25.2 (3.3)

Population analysed: Mass Balance Analysis Set: The mass balance analysis set was defined as all participants who received study intervention and who had evaluable total \[14C\] concentration (urinary and fecal) data and who had no protocol deviations or AEs (such as diarrhea or severe constipation) that might have affected the mass balance analysis.

Primary outcome: The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered

Time frame: from pre-dose to 216h post the start of infusion. Mean (Standard Deviation). Unit: percentage of dose

Measure	14C-PF-07304814 500 mg IV n = 5
Value	34.0 (4.7)

Primary outcome: The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)

Time frame: from pre-dose to 216h post the start of infusion. Mean (Standard Deviation). Unit: percentage of dose

Measure	14C-PF-07304814 500 mg IV n = 5
Value	59.2 (3.9)

Primary outcome: Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma PF-07304814 and Plasma PF-00835231

Time frame: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	14C-PF-07304814 500 mg IV n = 5
plasma PF-07304814	7322 (23)
plasma PF-00835231	22350 (13)

Population analysed: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the parameters of primary interest in plasma, urine or feces.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose to 28-35 days from administration of the dose of study intervention (maximum of 35 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
14C-PF-07304814 500 mg IV	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07304814 in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered (time frame: from pre-dose to 216h post the start of infusion). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05050682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.