Phase 1 N=5 Treatment

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT05050682 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered — 25.2 percentage of dose

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-07304814 (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered	25.2	—
PRIMARY The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered	34.0	—
PRIMARY The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)	59.2	—
PRIMARY 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	7322; 22350	—
PRIMARY Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]	468800	—
PRIMARY Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231	22620	—
PRIMARY AUCinf for Plasma Total [14C]	—	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231	359.8; 1044	—
PRIMARY Cmax for Plasma Total [14C]	8258	—
PRIMARY Time for Cmax (Tmax) for Plasma PF-07304814 and Plasma PF-00835231	12; 24.0	—
PRIMARY Tmax for Plasma Total 14C	24.0	—
PRIMARY Obsereved Plasma Concentration at 24 Hours (C24) for Plasma PF-07304814 and Plasma PF-00835231	313.9; 1044	—
PRIMARY C24 for Plasma Total [14C]	8258	—
PRIMARY Systematic Clearance (CL) for Plasma PF-07304814	—	—
PRIMARY Steady-state Volume of Distribution Following Intravenous Infusion (Vss) for Plasma PF-07304814	—	—
PRIMARY Terminal Elimination Half-life (t½) for Plasma PF-00835231	1.496	—
PRIMARY t½ for Plasma Total [14C]	—	—
SECONDARY Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814	0.4; 1.1; 21.5; 21.5; 0.4; 9.8	—
SECONDARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	3; 2; 0	—
SECONDARY Number of Subjects With Vital Signs Data Meeting Categorical Summarization Criteria	—	—
SECONDARY Number of Subjects With Laboratory Test Abnormalities (Without Regards to Baseline Abnormality)	1	—
SECONDARY Number of Subjects With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria	—	—

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

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).
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05050682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.