A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People

COVID-19: A MULTIPART, PHASE 1 STUDY WITH RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07817883 AND OPTIONAL OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE RELATIVE BIOAVAILABILITY AND FOOD EFFECT OF SOLID ORAL FORMULATION AND OPTIONAL OPEN-LABEL, NON-RANDOMIZED STUDY TO EVALUATE METABOLISM AND EXCRETION OF PF-07817883 AND OPTIONAL RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE EFFECT OF PF-07817883 ON PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-07817883; Drug: Placebo; Drug: Midazolam; Drug: Moxifloxacin

Detailed Description

Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
• Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs). A body weight of >45 kg may be considered in selected cases.
• Japanese subjects who have four Japanese biologic grandparents born in Japan
• Chinese participants who were born in mainland China and both parents are of the Chinese descent.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
• Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
• Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
• Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

25

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07817883 Dose 1 in PART-1	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 Dose 2 in PART-1	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 Dose 3 in PART-1	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 Dose 4 in PART-1	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 Dose 5 in PART-1; Optional dose levels	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 Dose 6 in PART-1; Optional dose levels	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Placebo Comparator: Placebo in PART-1; A single dose of placebo	Drug: Placebo; Placebo suspension
Experimental: PF-07817883 DR1 in PART-2; DR=Dosing regimen; twice a day	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 DR2 in PART-2	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 DR3 in PART-2; Optional dosing regimen	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 DR4 in PART-2; Optional dosing regimen	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 in Japanese in PART-2; Optional dosing regimen to be studied in Japanese population	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 in Chinese in PART-2; Optional dosing regimen to be studied in Chinese population	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Placebo Comparator: Placebo in PART-2	Drug: Placebo; Placebo suspension
Experimental: PF-07817883 Suspension Fasted in PART-3; PART-3 is optional	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 FORM-1 Fasted in PART-3; First solid oral formulation (FORM1)	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 FORM-2 Fasted in PART-3; Second solid oral formulations (FORM-2) is optional	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 FORM-1 Fed in PART-3	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 FORM-2 Fed in PART-3	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: PF-07817883 in PART-4; PART-4 is optional	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Experimental: Midazolam 5 mg in PART-5; Single dose of 5 mg alone	Drug: Midazolam; midazolam oral solution
Experimental: Midazolam 5 mg with PF-07817883 in PART-5; Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883	Drug: PF-07817883; Oral suspension or solid oral formulation(s); Drug: Midazolam; midazolam oral solution
Experimental: PF-07817883 in PART-6; A single dose at supratherapeutic exposure administered as divided doses (1h apart)	Drug: PF-07817883; Oral suspension or solid oral formulation(s)
Placebo Comparator: Placebo in PART-6; A single dose of placebo administered as divided doses (1h apart)	Drug: Placebo; Placebo suspension
Active Comparator: Moxifloxacin 400 mg in PART-6 (open label); Moxifloxacin 400 mg at 0h followed by placebo at 1h	Drug: Placebo; Placebo suspension; Drug: Moxifloxacin; Moxifloxacin 400 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-1:single ascending dose (SAD)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 5
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1:SAD	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 5
Number of Participants With Laboratory Abnormalities in PART-1:SAD	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 5
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-1:SAD	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 5
Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-2:multiple ascending dose (MAD)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 12
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2:MAD	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 12
Number of Participants With Laboratory Abnormalities in PART-2:MAD	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 12
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-2:MAD	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 12
The ratio of AUClast in PART-3:relative bioavailability (RBA)/food effect (FE)	The ratio of AUClast of test vs reference formulation	Day 1 to Day 3
The ratio of Cmax in PART-3:relative bioavailability (RBA)/food effect (FE)	The ratio of Cmax of test vs reference formulation	Day 1 to Day 3
Total % cumulative recovery of drug related material in urine and feces combined in PART-4: Metabolism and Excretion (ME)	Drug related material excreted in urine and feces combined	Day 1 to Day 11
Total % cumulative recovery of drug related material in urine combined in PART-4: Metabolism and Excretion (ME)	Drug related material excreted in urine	Day 1 to Day 11
Total % cumulative recovery of drug related material in feces combined in PART-4: Metabolism and Excretion (ME)	Drug related material excreted in feces	Day 1 to Day 11
Ratio of midazolam AUCinf or AUClast of test versus reference in PART-5:drug-drug interaction (DDI)	Ratio of midazolam AUCinf (if data permit) or AUClast of test (midazolam with PF-07817883) versus reference (midazolam alone)	Day 1 to Day 12
Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-6: Supratherapeutic Exposure (SE)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 6
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-6:SE	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 6
Number of Participants With Laboratory Abnormalities in PART-6:SE	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 6
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-6:SE	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) in PART-1:SAD	The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations	Day 1 to Day 5
Time for Cmax (Tmax) in PART-1:SAD	Observed directly from data as time of first occurrence.	Day 1 to Day 5
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in PART-1:SAD	AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.	Day 1 to Day 5
Dose Normalized Cmax (Cmax[dn]) in PART-1:SAD	Cmax(dn) = Cmax / dose.	Day 1 to Day 5
Dose Normalized AUClast (AUClast[dn]) in PART-1:SAD	AUClast /dose	Day 1 to Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) in PART-1:SAD	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 to Day 5
Dose normalized AUCinf (AUCinf[dn]) in PART-1:SAD	AUCinf/dose	Day 1 to Day 5
Plasma Decay Half-life (t1/2) in PART-1:SAD	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 to Day 5
Apparent Volume of Distribution (Vz/F) in PART-1:SAD	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Day 1 to Day 5
Apparent Oral Clearance (CL/F) in PART-1:SAD	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Day 1 to Day 5
Cmax on Day 1 in PART-2:MAD		Day 1 Pre-dose (0 hours) to 12 hours
Tmax on Day 1 in PART-2:MAD		Day 1 Pre-dose (0 hours) to 12 hours
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 in PART-2:MAD	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	Day 1 Pre-dose (0 hours) to 12 hours
Cmax[dn] on Day 1 in PART-2:MAD	Cmax(dn) = Cmax / dose.	Day 1 Pre-dose (0 hours) to 12 hours
AUCtau[dn] on Day 1 in PART-2:MAD	AUCtau/dose	Day 1 Pre-dose (0 hours) to 12 hours
Average concentration (Cav) on Day 1 in PART-2:MAD	AUCtau/12	Day 1 Pre-dose (0 hours) to 12 hours
Concentration at 12h post-dose (C12) on Day 5 in PART-2:MAD	Directly observed from the data.	Day 5 Pre-dose (0 hours) to 12 hours
Cmax on Day 5 in PART-2:MAD		Day 5 Pre-dose (0 hours) to 12 hours
Tmax on Day 5 in PART-2:MAD		Day 5 Pre-dose (0 hours) to 12 hours
AUCtau on Day 5 in PART-2:MAD	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	Day 5 Pre-dose (0 hours) to 12 hours
Cmax[dn] on Day 5 in PART-2:MAD	Cmax(dn) = Cmax / dose.	Day 5 Pre-dose (0 hours) to 12 hours
AUCtau[dn] on Day 5 in PART-2:MAD	AUCtau/dose	Day 5 Pre-dose (0 hours) to 12 hours
Average concentration (Cav) on Day 5 in PART-2:MAD	AUCtau/12	Day 5 Pre-dose (0 hours) to 12 hours
Peak Trough Ratio (PTR) Day 5 in PART-2:MAD	PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .	Day 5 Pre-dose (0 hours) to 12 hours
Observed Accumulation Ratio Based on AUC (Rac) on Day 5 in PART-2:MAD	Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 5) / AUCtau(Day 1). Rac is summarized by dosing regimen.	Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) on Day 5 in PART-2:MAD	Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day5) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen.	Day 5 Pre-dose (0 hours) to 12 hours
CL/F on Day 5 in PART-2:MAD	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Day 5 Pre-dose (0 hours) to 12 hours
Cmax on Day 10 in PART-2:MAD		Day 10 Pre-dose (0 hours) to 12 hours
C12 on Day 10 in PART-2:MAD	Directly observed from the data.	Day 10 Pre-dose (0 hours) to 12 hours
Tmax on Day 10 in PART-2:MAD		Day 10 Pre-dose (0 hours) to 12 hours
AUCtau on Day 10 in PART-2:MAD	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	Day 10 Pre-dose (0 hours) to 12 hours
Cmax[dn] on Day 10 in PART-2:MAD	Cmax(dn) = Cmax / dose.	Day 10 Pre-dose (0 hours) to 12 hours
AUCtau[dn] on Day 10 in PART-2:MAD	AUCtau/dose	Day 10 Pre-dose (0 hours) to 12 hours
Cav on Day 10 in PART-2:MAD	AUCtau/12	Day 10 Pre-dose (0 hours) to 12 hours
PTR Day 10 in PART-2:MAD	PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .	Day 10 Pre-dose (0 hours) to 12 hours
Rac on Day 10 in PART-2:MAD	Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 5) / AUCtau(Day 1). Rac is summarized by dosing regimen.	Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5
Rac,Cmax on Day 10 in PART-2:MAD	Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day5) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen.	Day 10 Pre-dose (0 hours) to 12 hours
CL/F on Day 10 in PART-2:MAD	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Day 10 Pre-dose (0 hours) to 12 hours
t1/2 on Day 10 in PART-2:MAD	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 10 to Day 12
Vz/F on Day 10 in PART-2:MAD		Day 10 to Day 12
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau) on Day 10 in PART-2:MAD	Sum of (urine volume × urine concentration) for each collection over the dosing interval tau. Dosing interval (tau) is 12 h for BID dosing.	Day 10 Pre-dose (0 hours) to 12 hours
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau%) on Day 10 in PART-2:MAD	Aetau% = Aetau / Dose * 100. Aetau% is summarized by dosing regimen. Dosing interval (tau) 12 h for BID dosing.	Day 10 Pre-dose (0 hours) to 12 hours
Renal Clearance (Clr) on Day 10 in MAD	Renal clearance is calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dosing.	Day 10 Pre-dose (0 hours) to 12 hours
The ratio of AUClast in PART-3:RBA/FE	The ratio of AUClast of test (fed) vs reference (fasted)	Day 1 to Day 3
The ratio of Cmax in PART-3:RBA/FE	The ratio of Cmax of test (fed) vs reference (fasted)	Day 1 to Day 3
The ratio of AUCinf in PART-3:RBA/FE	The ratio of AUCinf of test (fed) vs reference (fasted)	Day 1 to Day 3
Cmax in PART-3:RBA/FE		Day 1 to Day 3
Tmax in PART-3:RBA/FE	Observed directly from data as time of first occurrence.	Day 1 to Day 3
AUClast in PART-3:RBA/FE	AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.	Day 1 to Day 3
AUCinf in PART-3:RBA/FE	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 to Day 3
t1/2 in PART-3:RBA/FE	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 to Day 3
Vz/F in PART-3:RBA/FE	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Day 1 to Day 3
CL/F in PART-3:RBA/FE	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Day 1 to Day 3
Cmax in PART-4:ME		Day 1 to Day 4
Tmax in PART-4:ME	Observed directly from data as time of first occurrence.	Day 1 to Day 4
AUClast in PART-4:ME	AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.	Day 1 to Day 4
AUCinf in PART-4:ME	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 to Day 4
t1/2 in PART-4:ME	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 to Day 4
Vz/F in PART-4:ME	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Day 1 to Day 4
CL/F in PART-4:ME	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Day 1 to Day 4
Cmax of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
Cmax of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
Tmax of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
Tmax of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
AUClast of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
AUClast of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
AUCinf of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
AUCinf of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
CL/F of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
CL/F of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
Vz/F of midazolam, when administered alone, in PART-5:DDI		Day 1 to Day 3
Vz/F of midazolam, when administered with PF-07817883, in PART-5:DDI		Day 1 to Day 3
Number of participants with TEAEs in PART-3:RBA/FE	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 3
Number of participants with TEAEs in PART-4:ME	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 11
Number of participants with TEAEs in PART-5:DDI	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment	Day 1 to Day 12
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-3:RBA/FE	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 3
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-4:ME	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 11
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5:DDI	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Day 1 to Day 12
Number of Participants With Laboratory Abnormalities in PART-3:RBA/FE	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 3
Number of Participants With Laboratory Abnormalities in PART-4:ME	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 11
Number of Participants With Laboratory Abnormalities in PART-5:DDI	Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).	Day 1 to Day 12
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-3:RBA/FE	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 3
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-4:ME	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 11
Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-5:DDI	Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG	Day 1 to Day 12
Cmax in PART-6:SE	The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations	Day 1 to Day 6
Tmax in PART-6:SE	Observed directly from data as time of first occurrence.	Day 1 to Day 6
AUClast in PART-6:SE	AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.	Day 1 to Day 6
AUCinf in PART-6:SE	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 to Day 6
t1/2 in PART-6:SE	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 to Day 6

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Protease Inhibitor; Oral Antiviral; Mpro; PF-07817883
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Moxifloxacin
• Other Study ID Numbers: C5091001; 2022-002871-12 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No