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PF-07817883

Phase 2

SARS-CoV-2 Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 19, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

PF-07817883 · 5 trials · 3 indications

Phase 2 1Phase 1 4
NCT05799495A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not HospitalizedSARS-CoV-2 Infection
COMPLETED240 Analytics
PHASE2COMPLETED
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
SARS-CoV-2 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5
Baseline (Day 1), Day 5

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.

Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Day 1 to Day 5

Plasma PF-07817883 PK parameters

Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Day 1 to Day 5

Plasma PF-07817883 PK parameters

Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Day 1 to Day 5

Plasma PF-07817883 parameters

Maximum Observed Concentration (Cmax) of PF-07817883
Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL).

Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

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).

Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)

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.

Part 1: Number of Participants With Laboratory Test Abnormalities
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)

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.

Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Up to Day 2 of each period

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.

Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities
Up to Day 2 of each period

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.

Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)

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.

Part 2: Number of Participants With Laboratory Test Abnormalities
From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)

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.

Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Up to Day 12

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.

Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities
Up to Day 12

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.

Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

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.

Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

Data for Cmax are reported in the descriptive section. Ratio based on Cmax of oral formulation and suspension were reported in statistical analysis.

Part 4: Percentage of Total Dose Administered Recovered in Urine
Up to 144 hours post-dose

The percentage of total dose administered recovered in urine was reported in this outcome measure.

Part 4: Percentage of Total Dose Administered Recovered in Feces
Up to 144 hours post-dose

The percentage of total dose administered recovered in feces was reported in this outcome measure.

Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces
Up to 144 hours post-dose

The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.

Part 5: Maximum Observed Concentration (Cmax) of Midazolam
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm

Cmax of midazolam was reported in this outcome measure.

Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm

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.

Part 6: Number of Participants With TEAEs
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)

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.

Part 6: Number of Participants With Laboratory Test Abnormalities
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)

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.

Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Up to Day 6 of each period

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.

Part 6: Number of Participants According to Categorization of ECG Data
Up to Day 6 of each period

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.

Secondary Endpoints

Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
Baseline (Day 1), Day 3, Day 10 and Day 14
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations
From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: low doseEXPERIMENTAL -
Arm 2: medium doseEXPERIMENTAL -
Arm 3: high doseEXPERIMENTAL -
Arm 4: PlaceboPLACEBO_COMPARATOR -
Cohort 1EXPERIMENTALNo renal impairment
Cohort 2EXPERIMENTALSevere renal impairment
Cohort 3EXPERIMENTALModerate renal impairment
Cohort 4EXPERIMENTALSevere hepatic impairment
Period 1EXPERIMENTALThe treatment arm includes a single dose of PF-07817883 (Period 1 Day 1)
Period 2EXPERIMENTALThis 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-1EXPERIMENTAL -
PF-07817883 Dose 2 in PART-1EXPERIMENTAL -
PF-07817883 Dose 3 in PART-1EXPERIMENTAL -
PF-07817883 Dose 4 in PART-1EXPERIMENTAL -
PF-07817883 Dose 5 in PART-1EXPERIMENTALOptional dose levels
PF-07817883 Dose 6 in PART-1EXPERIMENTALOptional dose levels
Placebo in PART-1PLACEBO_COMPARATORA single dose of placebo
PF-07817883 DR1 in PART-2EXPERIMENTALDR=Dosing regimen; twice a day
PF-07817883 DR2 in PART-2EXPERIMENTAL -
PF-07817883 DR3 in PART-2EXPERIMENTALOptional dosing regimen
PF-07817883 DR4 in PART-2EXPERIMENTALOptional dosing regimen
PF-07817883 in Japanese in PART-2EXPERIMENTALOptional dosing regimen to be studied in Japanese population
PF-07817883 in Chinese in PART-2EXPERIMENTALOptional dosing regimen to be studied in Chinese population
Placebo in PART-2PLACEBO_COMPARATOR -
PF-07817883 Suspension Fasted in PART-3EXPERIMENTALPART-3 is optional
PF-07817883 FORM-1 Fasted in PART-3EXPERIMENTALFirst solid oral formulation (FORM1)
PF-07817883 FORM-2 Fasted in PART-3EXPERIMENTALSecond solid oral formulations (FORM-2) is optional
PF-07817883 FORM-1 Fed in PART-3EXPERIMENTAL -
PF-07817883 FORM-2 Fed in PART-3EXPERIMENTAL -
PF-07817883 in PART-4EXPERIMENTALPART-4 is optional
Midazolam 5 mg in PART-5EXPERIMENTALSingle dose of 5 mg alone
Midazolam 5 mg with PF-07817883 in PART-5EXPERIMENTALSingle dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883
PF-07817883 in PART-6EXPERIMENTALA single dose at supratherapeutic exposure administered as divided doses (1h apart)
Placebo in PART-6PLACEBO_COMPARATORA single dose of placebo administered as divided doses (1h apart)
Moxifloxacin 400 mg in PART-6 (open label)ACTIVE_COMPARATORMoxifloxacin 400 mg at 0h followed by placebo at 1h

Interventions

NameTypeDescription
PF-07817883DRUGArm 1: low dose Arm 2: medium dose Arm 3: high dose
PlaceboDRUGPlacebo
ItraconazoleDRUGInteracting drug which will be given for 7 days in period 2
MidazolamDRUGmidazolam oral solution
MoxifloxacinDRUGMoxifloxacin 400 mg tablet
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites53

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...

Countries:United StatesBelgium
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Frequently asked questions about PF-07817883

What is PF-07817883 used for?

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.

What does PF-07817883 target?

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.

Who makes PF-07817883?

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.

What phase is PF-07817883 in?

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.

What clinical trials is PF-07817883 in?

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.

Is PF-07817883 the same as Paxlovid?

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.