Trial Outcomes & Findings for Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants (NCT NCT05050682)

Results Overview

Obsereved plasma concentration at 24 hours. This was observed directly from data.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

24 hours post the start of infusion

Results posted on

2025-10-20

Participant Flow

A total of 5 participants were assigned to the study intervention and completed the study.

Participant milestones

Participant milestones
Measure	14C-PF-07304814 500 mg IV Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Age, Continuous	40.0 years n=5 Participants
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18-25 years	1 Participants n=5 Participants
Age, Customized 26-35 years	1 Participants n=5 Participants
Age, Customized 36-45 years	2 Participants n=5 Participants
Age, Customized >45 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: from pre-dose to 216h post the start of infusion

Population: 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.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
The Mean (SD) Amount of [14C] Recovered in Urine, as a Percent of the Total [14C] Dose Administered	25.2 percentage of dose Standard Deviation 3.3

PRIMARY outcome

Timeframe: from pre-dose to 216h post the start of infusion

Population: 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.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
The Mean (SD) Amount of [14C] Recovered in Feces, as a Percent of the Total [14C] Dose Administered	34.0 percentage of dose Standard Deviation 4.7

PRIMARY outcome

Timeframe: from pre-dose to 216h post the start of infusion

Population: 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.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
The Mean (SD) Percentage of [14C] Relative to the Administered Dose in Excreta (Urine + Feces)	59.2 percentage of dose Standard Deviation 3.9

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV 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 plasma PF-07304814	7322 ng*hr/mL Geometric Coefficient of Variation 23
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 plasma PF-00835231	22350 ng*hr/mL Geometric Coefficient of Variation 13

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Plasma Total [14C]	468800 ngEq*hr/mL Geometric Coefficient of Variation 16

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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. Data could not be estimated for AUCinf for the phosphate prodrug PF-07304814 due to the lack of a well characterized terminal elimination phase. A well characterized terminal phase is defined as one with at least 3 data points can be used for log-linear regression, r2 ≥0.9, and AUCextrap% ≤ 20%.

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).

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Area Under the Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Plasma PF-00835231 plasma PF-00835231	22620 ng*hr/mL Geometric Coefficient of Variation 13

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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. AUCinf values were not reported for the total \[14C\] due to the lack of a well characterized terminal elimination phase. A well characterized terminal phase is defined as one with at least 3 data points can be used for log-linear regression, r2 ≥0.9, and AUCextrap% ≤ 20%.

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Maximum observed plasma concentration. This was observed directly from data.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-07304814	359.8 ng/mL Geometric Coefficient of Variation 24
Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-00835231	1044 ng/mL Geometric Coefficient of Variation 11

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Maximum observed plasma concentration. This was observed directly from data.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Cmax for Plasma Total [14C]	8258 ngEq/mL Geometric Coefficient of Variation 11

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Time for Cmax. This was observed directly from data as time of first occurrence.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Time for Cmax (Tmax) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-07304814	12 hour Interval 2.02 to 24.0
Time for Cmax (Tmax) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-00835231	24.0 hour Interval 24.0 to 24.0

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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.

Time for Cmax. This was observed directly from data as time of first occurrence.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Tmax for Plasma Total 14C	24.0 hour Interval 24.0 to 24.0

PRIMARY outcome

Timeframe: 24 hours post the start of infusion

Population: 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.

Obsereved plasma concentration at 24 hours. This was observed directly from data.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Obsereved Plasma Concentration at 24 Hours (C24) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-07304814	313.9 ng/mL Geometric Coefficient of Variation 19
Obsereved Plasma Concentration at 24 Hours (C24) for Plasma PF-07304814 and Plasma PF-00835231 plasma PF-00835231	1044 ng/mL Geometric Coefficient of Variation 11

PRIMARY outcome

Timeframe: 24hours post the start of infusion

Population: 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.

Obsereved plasma concentration at 24 hours. This was observed directly from data.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
C24 for Plasma Total [14C]	8258 ngEq/mL Geometric Coefficient of Variation 11

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: 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. CL values were not reported for the phosphate prodrug PF-07304814 due to the lack of a well characterized terminal elimination phase. A well characterized terminal phase is defined as one with at least 3 data points can be used for log-linear regression, r2 ≥0.9, and AUCextrap% ≤ 20%.

Systemic clearance. This was determined by Dose/AUCinf (if data permit).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the parameters of primary interest in plasma, urine or feces. Vss values were not reported for the phosphate prodrug PF-07304814 due to the lack of a well characterized terminal elimination phase. A well characterized terminal phase is defined as one with at least 3 data points can be used for log-linear regression, r2 ≥0.9, and AUCextrap% ≤ 20%.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the parameters of primary interest in plasma, urine or feces. Data could not be estimated for t½ for the phosphate prodrug PF-07304814 due to the lack of a well characterized terminal elimination phase. A well characterized terminal phase is defined as one with at least 3 data points can be used for log-linear regression, r2 ≥0.9, and AUCextrap% ≤ 20%.

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).

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Terminal Elimination Half-life (t½) for Plasma PF-00835231 plasma PF-00835231	1.496 hour Standard Deviation 0.30088

PRIMARY outcome

Timeframe: pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion

Population: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the parameters of primary interest in plasma, urine or feces. t½ values were not reported for the total \[14C\] due to the lack of a well characterized terminal elimination phase.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose to maximum of Day 10

Population: The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the parameters of primary interest in plasma, urine or feces. Data reported with measure type "Number" as the values reported represent the measured value from a pooled sample from all participants in the study.

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).

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M12: plasma	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M8: plasma	1.1 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M7: plasma	21.5 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 PF-07304814 and epimer: plasma	21.5 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M6: plasma	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 PF-00835231: plasma	9.8 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 Epimer (PF-03626560): plasma	1.3 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 467: urine	0.3 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M12: urine	1.7 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M8: urine	2.3 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M7 (PF-07305457): urine	5.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M11a: urine	2.1 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M11b: urine	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M11c: urine	0.5 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M11d: urine	0.6 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M6: urine	0.3 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 475: urine	0.3 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 PF-00835231: urine	7.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 Epimer (PF-03626560): urine	0.6 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 287: urine	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 Unknown: feces	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 491: feces	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 487: feces	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M1 (PF-07307659): feces	0.8 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 M6: feces	2.6 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 m/z 475: feces	0.2 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 PF-00835231: feces	0.4 Percentage of Radioactivity
Percentage of Total Radioactivity in Each Matrix (Plasma, Urine and Feces) of Metabolites of PF-07304814 Epimer (PF-03626560): feces	0.9 Percentage of Radioactivity

SECONDARY outcome

Timeframe: From first dose up to 28-35 days from administration of the dose of study intervention (maximum of 35 days)

Population: The safety analysis set includes all participants assigned to study intervention and who take at least 1 dose of study intervention.

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

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) all causality AEs	3 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) treatment related AEs	2 Participants
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) serious adverse events	0 Participants

SECONDARY outcome

Timeframe: from Screening (Day-42 to Day-2) to 216h or early termination/discontinuation

Population: All participants assigned to study intervention and who take at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Number of Subjects With Vital Signs Data Meeting Categorical Summarization Criteria	0 Participants

SECONDARY outcome

Timeframe: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation

Population: All participants assigned to study intervention and who take at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Number of Subjects With Laboratory Test Abnormalities (Without Regards to Baseline Abnormality)	1 Participants

SECONDARY outcome

Timeframe: From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation

Population: All participants assigned to study intervention and who take at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	14C-PF-07304814 500 mg IV n=5 Participants Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Number of Subjects With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria	0 Participants

Adverse Events

14C-PF-07304814 500 mg IV

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	14C-PF-07304814 500 mg IV n=5 participants at risk Participants received 500 mg PF-07304814 containing approximately 420 nCi \[14C\] PF-07304814 starting at approximately 08:00 hour (±2 hours), administered as a single, 24-hour constant-rate, continuous IV infusion.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • From the first dose to 28-35 days from administration of the dose of study intervention (maximum of 35 days) Participants were only counted once per treatment for each category.
Gastrointestinal disorders Diarrhoea	40.0% 2/5 • Number of events 2 • From the first dose to 28-35 days from administration of the dose of study intervention (maximum of 35 days) Participants were only counted once per treatment for each category.
Skin and subcutaneous tissue disorders Erythema	20.0% 1/5 • Number of events 1 • From the first dose to 28-35 days from administration of the dose of study intervention (maximum of 35 days) Participants were only counted once per treatment for each category.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER