We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05580003
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-07817883 Drug: Placebo Drug: Midazolam Drug: Moxifloxacin Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Masking: Double (Participant, Investigator)
Masking Description: PART-1, 2 and 6 are double-blind, sponsor-open while PART-3, 4 and 5 are open label
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 17, 2022
Estimated Primary Completion Date : August 10, 2023
Estimated Study Completion Date : August 10, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Midazolam

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-1:single ascending dose (SAD) [ Time Frame: Day 1 to Day 5 ]
    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

  2. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  3. Number of Participants With Laboratory Abnormalities in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    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]).

  4. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    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

  5. Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-2:multiple ascending dose (MAD) [ Time Frame: Day 1 to Day 12 ]
    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

  6. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2:MAD [ Time Frame: Day 1 to Day 12 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  7. Number of Participants With Laboratory Abnormalities in PART-2:MAD [ Time Frame: Day 1 to Day 12 ]
    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]).

  8. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-2:MAD [ Time Frame: Day 1 to Day 12 ]
    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

  9. The ratio of AUClast in PART-3:relative bioavailability (RBA)/food effect (FE) [ Time Frame: Day 1 to Day 3 ]
    The ratio of AUClast of test vs reference formulation

  10. The ratio of Cmax in PART-3:relative bioavailability (RBA)/food effect (FE) [ Time Frame: Day 1 to Day 3 ]
    The ratio of Cmax of test vs reference formulation

  11. Total % cumulative recovery of drug related material in urine and feces combined in PART-4: Metabolism and Excretion (ME) [ Time Frame: Day 1 to Day 11 ]
    Drug related material excreted in urine and feces combined

  12. Total % cumulative recovery of drug related material in urine combined in PART-4: Metabolism and Excretion (ME) [ Time Frame: Day 1 to Day 11 ]
    Drug related material excreted in urine

  13. Total % cumulative recovery of drug related material in feces combined in PART-4: Metabolism and Excretion (ME) [ Time Frame: Day 1 to Day 11 ]
    Drug related material excreted in feces

  14. Ratio of midazolam AUCinf or AUClast of test versus reference in PART-5:drug-drug interaction (DDI) [ Time Frame: Day 1 to Day 12 ]
    Ratio of midazolam AUCinf (if data permit) or AUClast of test (midazolam with PF-07817883) versus reference (midazolam alone)

  15. Number of participants with Treatment Emergent Adverse Events (TEAEs) in PART-6: Supratherapeutic Exposure (SE) [ Time Frame: Day 1 to Day 6 ]
    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

  16. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  17. Number of Participants With Laboratory Abnormalities in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    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]).

  18. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    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


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations

  2. Time for Cmax (Tmax) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    Observed directly from data as time of first occurrence.

  3. Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

  4. Dose Normalized Cmax (Cmax[dn]) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    Cmax(dn) = Cmax / dose.

  5. Dose Normalized AUClast (AUClast[dn]) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    AUClast /dose

  6. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    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).

  7. Dose normalized AUCinf (AUCinf[dn]) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    AUCinf/dose

  8. Plasma Decay Half-life (t1/2) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  9. Apparent Volume of Distribution (Vz/F) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    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.

  10. Apparent Oral Clearance (CL/F) in PART-1:SAD [ Time Frame: Day 1 to Day 5 ]
    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.

  11. Cmax on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
  12. Tmax on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
  13. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  14. Cmax[dn] on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    Cmax(dn) = Cmax / dose.

  15. AUCtau[dn] on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose

  16. Average concentration (Cav) on Day 1 in PART-2:MAD [ Time Frame: Day 1 Pre-dose (0 hours) to 12 hours ]
    AUCtau/12

  17. Concentration at 12h post-dose (C12) on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Directly observed from the data.

  18. Cmax on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
  19. Tmax on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
  20. AUCtau on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  21. Cmax[dn] on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    Cmax(dn) = Cmax / dose.

  22. AUCtau[dn] on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose

  23. Average concentration (Cav) on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    AUCtau/12

  24. Peak Trough Ratio (PTR) Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .

  25. Observed Accumulation Ratio Based on AUC (Rac) on Day 5 in PART-2:MAD [ Time Frame: Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5 ]
    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.

  26. Observed Accumulation Ratio Based on Cmax (Rac,Cmax) on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    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.

  27. CL/F on Day 5 in PART-2:MAD [ Time Frame: Day 5 Pre-dose (0 hours) to 12 hours ]
    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.

  28. Cmax on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
  29. C12 on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Directly observed from the data.

  30. Tmax on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
  31. AUCtau on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  32. Cmax[dn] on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Cmax(dn) = Cmax / dose.

  33. AUCtau[dn] on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    AUCtau/dose

  34. Cav on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    AUCtau/12

  35. PTR Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen .

  36. Rac on Day 10 in PART-2:MAD [ Time Frame: Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5 ]
    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.

  37. Rac,Cmax on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    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.

  38. CL/F on Day 10 in PART-2:MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    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.

  39. t1/2 on Day 10 in PART-2:MAD [ Time Frame: Day 10 to Day 12 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  40. Vz/F on Day 10 in PART-2:MAD [ Time Frame: Day 10 to Day 12 ]
  41. 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 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Sum of (urine volume × urine concentration) for each collection over the dosing interval tau. Dosing interval (tau) is 12 h for BID dosing.

  42. 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 [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    Aetau% = Aetau / Dose * 100. Aetau% is summarized by dosing regimen. Dosing interval (tau) 12 h for BID dosing.

  43. Renal Clearance (Clr) on Day 10 in MAD [ Time Frame: Day 10 Pre-dose (0 hours) to 12 hours ]
    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.

  44. The ratio of AUClast in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    The ratio of AUClast of test (fed) vs reference (fasted)

  45. The ratio of Cmax in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    The ratio of Cmax of test (fed) vs reference (fasted)

  46. The ratio of AUCinf in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    The ratio of AUCinf of test (fed) vs reference (fasted)

  47. Cmax in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
  48. Tmax in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    Observed directly from data as time of first occurrence.

  49. AUClast in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

  50. AUCinf in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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).

  51. t1/2 in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  52. Vz/F in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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.

  53. CL/F in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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.

  54. Cmax in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
  55. Tmax in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    Observed directly from data as time of first occurrence.

  56. AUClast in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

  57. AUCinf in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    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).

  58. t1/2 in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  59. Vz/F in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    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.

  60. CL/F in PART-4:ME [ Time Frame: Day 1 to Day 4 ]
    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.

  61. Cmax of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  62. Cmax of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  63. Tmax of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  64. Tmax of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  65. AUClast of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  66. AUClast of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  67. AUCinf of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  68. AUCinf of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  69. CL/F of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  70. CL/F of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  71. Vz/F of midazolam, when administered alone, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  72. Vz/F of midazolam, when administered with PF-07817883, in PART-5:DDI [ Time Frame: Day 1 to Day 3 ]
  73. Number of participants with TEAEs in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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

  74. Number of participants with TEAEs in PART-4:ME [ Time Frame: Day 1 to Day 11 ]
    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

  75. Number of participants with TEAEs in PART-5:DDI [ Time Frame: Day 1 to Day 12 ]
    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

  76. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  77. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-4:ME [ Time Frame: Day 1 to Day 11 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  78. Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5:DDI [ Time Frame: Day 1 to Day 12 ]
    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.

  79. Number of Participants With Laboratory Abnormalities in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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]).

  80. Number of Participants With Laboratory Abnormalities in PART-4:ME [ Time Frame: Day 1 to Day 11 ]
    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]).

  81. Number of Participants With Laboratory Abnormalities in PART-5:DDI [ Time Frame: Day 1 to Day 12 ]
    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]).

  82. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-3:RBA/FE [ Time Frame: Day 1 to Day 3 ]
    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

  83. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-4:ME [ Time Frame: Day 1 to Day 11 ]
    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

  84. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in PART-5:DDI [ Time Frame: Day 1 to Day 12 ]
    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

  85. Cmax in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations

  86. Tmax in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    Observed directly from data as time of first occurrence.

  87. AUClast in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

  88. AUCinf in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    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).

  89. t1/2 in PART-6:SE [ Time Frame: Day 1 to Day 6 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05580003


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
United States, Connecticut
New Haven Clinical Research Unit Active, not recruiting
New Haven, Connecticut, United States, 06511
Belgium
Brussels Clinical Research Unit Recruiting
Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05580003    
Other Study ID Numbers: C5091001
2022-002871-12 ( EudraCT Number )
2022-002871-12 ( Registry Identifier: CTIS (EU) )
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Oral Antiviral
COVID-19
Protease Inhibitor
Mpro
PF-07817883
Additional relevant MeSH terms:
Layout table for MeSH terms
Moxifloxacin
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents