Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07817883 · 5 trials · 3 indications
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
Plasma PF-07817883 PK parameters
Plasma PF-07817883 PK parameters
Plasma PF-07817883 parameters
Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL).
AUCinf was derived by AUClast + (Clast\*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; Clast\* was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUCinf was measured in nanogram\*hour per milliliter (ng\*hr/mL).
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Laboratory parameters included: (lymphocytes less than (\<) 0.8\*lower limit of normal \[LLN\] \[10\^3 per millimeter cube {mm3}\], lymphocytes/leukocytes \<0.8\*LLN \[percentage {%}\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], monocytes/leukocytes greater than (\>) 1.2\*upper limit of normal \[ULN\] \[%\], partial thromboplastin time \>1.1\*ULN \[seconds\]), chemistry (bicarbonate \<0.9\*LLN \[milliequivalents per liter {mEq/L}\], creatine kinase \>2.0\*ULN \[units per liter {U/L}\], lipase \>1.5\*ULN \[U/L\]), and urinalysis (urine hemoglobin greater than or equal to \[\>=\] 1, leukocyte esterase \>=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\<) 90 millimeter of mercury (mmHg), change greater than or equal to (\>=) 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 beats per minute (bpm), value \> 120 bpm.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Laboratory parameters included: hematology (lymphocytes/leukocytes \>1.2\*ULN \[%\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], monocytes/leukocytes \>1.2\*ULN \[%\]), chemistry (urate \>1.2\*ULN \[milligrams per deciliter\] {mg/dL}), and urinalysis (ketones \>=1, urine hemoglobin \>=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of oral formulation and suspension were reported in statistical analysis.
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of oral formulation and suspension were reported in statistical analysis.
The percentage of total dose administered recovered in urine was reported in this outcome measure.
The percentage of total dose administered recovered in feces was reported in this outcome measure.
The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.
Cmax of midazolam was reported in this outcome measure.
AUCinf of midazolam was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Laboratory parameters included: hematology (lymphocytes \<0.6\*LLN \[10\^3/mm3\], lymphocytes/leukocytes \>1.2\*ULN \[%\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], basophils/leukocytes \>1.2\*ULN \[%\], eosinophils/leukocytes \>1.2\*ULN \[%\], monocytes/leukocytes \>1.2\*ULN \[%\], partial thromboplastin time \>1.1\*ULN \[seconds\], prothrombin time \>1.1\*ULN \[seconds\]), chemistry (bicarbonate \<0.9\*LLN \[mEq/L\], creatine kinase \> 2.0\*ULN \[U/L\], lipase \> 1.5\*ULN \[U/L\], urobilinogen \>=1 \[ehrlich units/deciliter\] {EU/dL}) and urinalysis (urine hemoglobin \>=1, leukocyte esterase \>=1, ketones \>=1, bacteria \>20 \[per low power field\] {/lpf}). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured QTcF interval, aggregate 450 milliseconds (msec) \< value \<= 480 msec and QTcF interval, aggregate 30 msec \< change \<= 60 msec. Number of participants with abnormalities in ECG were reported in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Arm 1: low dose | EXPERIMENTAL | - |
| Arm 2: medium dose | EXPERIMENTAL | - |
| Arm 3: high dose | EXPERIMENTAL | - |
| Arm 4: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | No renal impairment |
| Cohort 2 | EXPERIMENTAL | Severe renal impairment |
| Cohort 3 | EXPERIMENTAL | Moderate renal impairment |
| Cohort 4 | EXPERIMENTAL | Severe hepatic impairment |
| Period 1 | EXPERIMENTAL | The treatment arm includes a single dose of PF-07817883 (Period 1 Day 1) |
| Period 2 | EXPERIMENTAL | This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4) |
| PF-07817883 Dose 1 in PART-1 | EXPERIMENTAL | - |
| PF-07817883 Dose 2 in PART-1 | EXPERIMENTAL | - |
| PF-07817883 Dose 3 in PART-1 | EXPERIMENTAL | - |
| PF-07817883 Dose 4 in PART-1 | EXPERIMENTAL | - |
| PF-07817883 Dose 5 in PART-1 | EXPERIMENTAL | Optional dose levels |
| PF-07817883 Dose 6 in PART-1 | EXPERIMENTAL | Optional dose levels |
| Placebo in PART-1 | PLACEBO_COMPARATOR | A single dose of placebo |
| PF-07817883 DR1 in PART-2 | EXPERIMENTAL | DR=Dosing regimen; twice a day |
| PF-07817883 DR2 in PART-2 | EXPERIMENTAL | - |
| PF-07817883 DR3 in PART-2 | EXPERIMENTAL | Optional dosing regimen |
| PF-07817883 DR4 in PART-2 | EXPERIMENTAL | Optional dosing regimen |
| PF-07817883 in Japanese in PART-2 | EXPERIMENTAL | Optional dosing regimen to be studied in Japanese population |
| PF-07817883 in Chinese in PART-2 | EXPERIMENTAL | Optional dosing regimen to be studied in Chinese population |
| Placebo in PART-2 | PLACEBO_COMPARATOR | - |
| PF-07817883 Suspension Fasted in PART-3 | EXPERIMENTAL | PART-3 is optional |
| PF-07817883 FORM-1 Fasted in PART-3 | EXPERIMENTAL | First solid oral formulation (FORM1) |
| PF-07817883 FORM-2 Fasted in PART-3 | EXPERIMENTAL | Second solid oral formulations (FORM-2) is optional |
| PF-07817883 FORM-1 Fed in PART-3 | EXPERIMENTAL | - |
| PF-07817883 FORM-2 Fed in PART-3 | EXPERIMENTAL | - |
| PF-07817883 in PART-4 | EXPERIMENTAL | PART-4 is optional |
| Midazolam 5 mg in PART-5 | EXPERIMENTAL | Single dose of 5 mg alone |
| Midazolam 5 mg with PF-07817883 in PART-5 | EXPERIMENTAL | Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883 |
| PF-07817883 in PART-6 | EXPERIMENTAL | A single dose at supratherapeutic exposure administered as divided doses (1h apart) |
| Placebo in PART-6 | PLACEBO_COMPARATOR | A single dose of placebo administered as divided doses (1h apart) |
| Moxifloxacin 400 mg in PART-6 (open label) | ACTIVE_COMPARATOR | Moxifloxacin 400 mg at 0h followed by placebo at 1h |
| Name | Type | Description |
|---|---|---|
| PF-07817883 | DRUG | Arm 1: low dose Arm 2: medium dose Arm 3: high dose |
| Placebo | DRUG | Placebo |
| Itraconazole | DRUG | Interacting drug which will be given for 7 days in period 2 |
| Midazolam | DRUG | midazolam oral solution |
| Moxifloxacin | DRUG | Moxifloxacin 400 mg tablet |
Inclusion Criteria: 1. Participants ≥18 to \<65 years of age at the time of the Screening Visit. * WOCBP may be enrolled. * All fertile participants must agree to use a highly effective method of contraception. 2. Confirmed SARS-CoV-2 infection as determined by RAT in NP specimen collected w...
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PF-07817883 is an investigational small molecule being developed by Pfizer for the treatment and prevention of COVID-19, specifically targeting SARS-CoV-2 infection. It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers and patients with COVID-19 to evaluate its safety, tolerability, and pharmacokinetics.
PF-07817883 is designed to target SARS-CoV-2, the virus that causes COVID-19. As a small molecule antiviral, it is being studied for its potential to treat or prevent SARS-CoV-2 infection. The specific molecular target has not been disclosed in the available clinical trial information.
PF-07817883 is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting Phase 1 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational small molecule for COVID-19.
PF-07817883 is in Phase 1 clinical development. All four clinical trials listed for this drug are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities. It is being studied in healthy volunteers and in individuals with COVID-19 or hepatic and renal impairment.
PF-07817883 has been studied in four completed Phase 1 clinical trials: NCT05580003, a safety and blood level study in healthy people; NCT05822440, a drug interaction study with itraconazole; NCT05884554, a study of liver function effects on blood levels; and NCT06586216, a study of renal impairment effects on pharmacokinetics.
No, PF-07817883 is not the same as Paxlovid. Paxlovid is Pfizer's approved COVID-19 treatment combining nirmatrelvir and ritonavir. PF-07817883 is a separate investigational small molecule being studied in Phase 1 trials for COVID-19. It has not been approved and its mechanism of action may differ from Paxlovid.