Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05050682 | Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants | PHASE1 | COMPLETED | 5 | — | — | Oct 7, 2021 | Dec 10, 2021 | Oct 20, 2025 | 1 | United States |
| NCT04627532 | Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants | PHASE1 | COMPLETED | 16 | — | — | Oct 23, 2020 | Dec 17, 2020 | Jan 6, 2021 | 1 | United States |
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.
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.
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 (Clast), using linear/log trapezoidal method.
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. 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).
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. This was observed directly from data.
Maximum observed plasma concentration. This was observed directly from data.
Time for Cmax. This was observed directly from data as time of first occurrence.
Time for Cmax. This was observed directly from data as time of first occurrence.
Obsereved plasma concentration at 24 hours. This was observed directly from data.
Obsereved plasma concentration at 24 hours. This was observed directly from data.
Systemic clearance. This was determined by Dose/AUCinf (if data permit).
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. 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).
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).
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Percentage of subjects with laboratory abnormalities
blood pressure, pulse rate, temperature, respiration rate
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
| Arm | Type | Description |
|---|---|---|
| PF-07304814 | EXPERIMENTAL | PF-07304814 is an anti-viral, formulated for intravenous delivery |
| Treatment | EXPERIMENTAL | PF-07304814 assignment |
| Placebo | PLACEBO_COMPARATOR | Placebo assigned |
| Name | Type | Description |
|---|---|---|
| PF-07304814 | DRUG | PF-07304814 is an anti-viral, formulated for intravenous delivery |
| Placebo | DRUG | Participants will recieve placebo |
Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. 3. Participants who ...