Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT05050682 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07304814 | Experimental | PF-07304814 is an anti-viral, formulated for intravenous delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07304814 | Drug | PF-07304814 is an anti-viral, formulated for intravenous delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Predose to maximum of Day 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit - Madison | Madison | Wisconsin | 53704 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
A total of 5 participants were assigned to the study intervention and completed the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of dose | from pre-dose to 216h post the start of infusion |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | medDRA v24.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2021 | Dec 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2021 | Dec 5, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000714028 | lufotrelvir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 24 hours post the start of infusion |
| C24 for Plasma Total [14C] | Obsereved plasma concentration at 24 hours. This was observed directly from data. | 24hours post the start of infusion |
| Systematic Clearance (CL) for Plasma PF-07304814 | Systemic clearance. This was determined by Dose/AUCinf (if data permit). | 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. | 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). | 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). | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
| 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 |
| 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. | 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. | 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. | From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of dose | from pre-dose to 216h post the start of infusion |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of dose | from pre-dose to 216h post the start of infusion |
|
|
|
| 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 | Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), using linear/log trapezoidal method. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq*hr/mL | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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). | 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%. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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). | 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%. | Posted | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Plasma PF-07304814 and Plasma PF-00835231 | Maximum observed plasma concentration. This was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | Cmax for Plasma Total [14C] | Maximum observed plasma concentration. This was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq/mL | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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. | 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. | Posted | Median | Full Range | hour | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | Tmax for Plasma Total 14C | Time for Cmax. This was observed directly from data as time of first occurrence. | 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. | Posted | Median | Full Range | hour | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 24 hours post the start of infusion |
|
|
|
| Primary | C24 for Plasma Total [14C] | Obsereved plasma concentration at 24 hours. This was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq/mL | 24hours post the start of infusion |
|
|
|
| Primary | Systematic Clearance (CL) for Plasma PF-07304814 | Systemic clearance. This was determined by Dose/AUCinf (if data permit). | 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%. | Posted | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
| Primary | 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. | 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%. | Posted | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
| Primary | 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). | 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%. | Posted | Mean | Standard Deviation | hour | 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
|
| Primary | 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). | 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. | Posted | pre-dose, 0.5h, 1h, 2h, 6h, 12h, 24h, 25h, 27h, 32h, 48h, 72h, 96h, 120h, 144h, 216h post the start of infusion |
|
|
| Secondary | 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). | 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. | Posted | Number | Percentage of Radioactivity | Predose to maximum of Day 10 |
|
|
|
| Secondary | 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 | The safety analysis set includes all participants assigned to study intervention and who take at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose up to 28-35 days from administration of the dose of study intervention (maximum of 35 days) |
|
|
|
| Secondary | 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. | All participants assigned to study intervention and who take at least 1 dose of study intervention. | Posted | Count of Participants | Participants | from Screening (Day-42 to Day-2) to 216h or early termination/discontinuation |
|
|
|
| Secondary | 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. | All participants assigned to study intervention and who take at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation |
|
|
|
| Secondary | 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. | All participants assigned to study intervention and who take at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Screening (Day-42 to Day-2) to 216h or early termination/discontinuation |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| Diarrhoea | Gastrointestinal disorders | medDRA v24.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | medDRA v24.1 | Non-systematic Assessment |
|
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.
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| PF-07304814 and epimer: plasma |
|
| M6: plasma |
|
| PF-00835231: plasma |
|
| Epimer (PF-03626560): plasma |
|
| m/z 467: urine |
|
| M12: urine |
|
| M8: urine |
|
| M7 (PF-07305457): urine |
|
| M11a: urine |
|
| M11b: urine |
|
| M11c: urine |
|
| M11d: urine |
|
| M6: urine |
|
| m/z 475: urine |
|
| PF-00835231: urine |
|
| Epimer (PF-03626560): urine |
|
| m/z 287: urine |
|
| Unknown: feces |
|
| m/z 491: feces |
|
| m/z 487: feces |
|
| M1 (PF-07307659): feces |
|
| M6: feces |
|
| m/z 475: feces |
|
| PF-00835231: feces |
|
| Epimer (PF-03626560): feces |
|
| Title | Measurements |
|---|---|
|