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OpenTrials
Completed

NCT Number: NCT05050682

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

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

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Key information

Conditions

Healthy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit - Madison

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • Participants whose occupation requires exposure to radiation or monitoring of radiation exposure.
  • 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.

Treatment and study plan

PF-07304814

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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.

  16. 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).

  17. 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).

Secondary outcomes

  1. Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814

    Time frame: Predose to maximum of Day 10

    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).

  2. 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)

    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

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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