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Completed

NCT Number: NCT05580003

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

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.

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Key information

Conditions

Healthy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région de, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07817883

Drug

Oral suspension or solid oral formulation(s)

Placebo

Drug

Placebo suspension

midazolam

Drug

midazolam oral solution

moxifloxacin

Drug

Moxifloxacin 400 mg tablet

Primary outcomes

  1. Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 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.

  2. Part 1: Number of Participants With Laboratory Test Abnormalities

    Time frame: 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.

  3. Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: 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.

  4. Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities

    Time frame: 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.

  5. Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 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.

  6. Part 2: Number of Participants With Laboratory Test Abnormalities

    Time frame: 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.

  7. Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: 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.

  8. Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities

    Time frame: 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.

  9. 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

    Time frame: 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.

  10. Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension

    Time frame: 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.

  11. Part 4: Percentage of Total Dose Administered Recovered in Urine

    Time frame: Up to 144 hours post-dose

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

  12. Part 4: Percentage of Total Dose Administered Recovered in Feces

    Time frame: Up to 144 hours post-dose

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

  13. Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces

    Time frame: Up to 144 hours post-dose

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

  14. Part 5: Maximum Observed Concentration (Cmax) of Midazolam

    Time frame: 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.

  15. Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam

    Time frame: 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.

  16. Part 6: Number of Participants With TEAEs

    Time frame: 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.

  17. Part 6: Number of Participants With Laboratory Test Abnormalities

    Time frame: 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.

  18. Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: 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.

  19. Part 6: Number of Participants According to Categorization of ECG Data

    Time frame: 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 outcomes

  1. Part 1: Maximum Observed Concentration (Cmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Cmax of PF-07817883 was reported in this outcome measure.

  2. Part 1: Time for Cmax (Tmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Tmax of PF-07817883 was reported in this outcome measure.

  3. Part 1: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

  4. Part 1: Dose Normalized Cmax (Cmax[dn]) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.

  5. Part 1: Dose Normalized AUClast (AUClast[dn]) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUClast(dn) of PF-07817883 was reported in this outcome measure. AUClast(dn) was calculated by AUClast/dose.

  6. Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUCinf of PF-07817883 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.

  7. Part 1: Dose Normalized AUCinf (AUCinf[dn]) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUCinf(dn) of PF-07817883 was reported in this outcome measure. AUCinf(dn) was calculated as AUCinf/dose.

  8. Part 1: Terminal Half-Life (t1/2) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

  9. Part 1: Apparent Volume of Distribution (Vz/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf*kel).

  10. Part 1: Apparent Clearance (CL/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

  11. Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10

    Time frame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Cmax of PF-07817883 was reported in this outcome measure.

  12. Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10

    Time frame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Tmax of PF-07817883 was reported in this outcome measure.

  13. Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10

    Time frame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)

    AUCtau was defined as area under the plasma concentration-time profile from time 0 to time tau, the dosing interval, where tau= 12 hours. AUCtau of PF-07817883 was reported in this outcome measure. AUCtau was calculated by linear/log trapezoidal method.

  14. Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10

    Time frame: 12 hours on Day 5 and Day 10

    C12 of PF-07817883 was reported in this outcome measure.

  15. Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10

    Time frame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.

  16. Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10

    Time frame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)

    AUCtau(dn) was defined as dose normalized AUCtau, where tau= 12 hours. AUCtau(dn) of PF-07817883 was reported in this outcome measure. AUCtau(dn) was calculated as AUCtau/dose.

  17. Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10

    Time frame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)

    Cav of PF-07817883 was reported in this outcome measure. Cav was calculated as AUCtau/12.

  18. Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10

    Time frame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)

    Rac was defined as observed accumulation ratio for AUCtau, where tau= 12 hours. Rac of PF-07817883 was reported in this outcome measure. Rac was calculated as AUCtau on Day 5 or Day 10/AUCtau on Day 1.

  19. Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10

    Time frame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Rac,Cmax of PF-07817883 was reported in this outcome measure. Rac,Cmax was calculated as Cmax on Day 5 or Day 10/Cmax on Day 1.

  20. Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10

    Time frame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    PTR of PF-07817883 was reported in this outcome measure. PTR was calculated as Cmax/Cmin.

  21. Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10

    Time frame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

  22. Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).

  23. Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

  24. Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10

    Time frame: Day 10 (0 to 12 hours)

    Aetau was defined as amount excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau of PF-07817883 was reported in this outcome measure. Aetau was calculated as sum of (urine volume*urine concentration) for each collection over the dosing interval.

  25. Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10

    Time frame: Day 10 (0 to 12 hours)

    Aetau% was defined as percentage of dose excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau% of PF-07817883 was reported in this outcome measure. Aetau% was calculated as 100*Aetau/dose.

  26. Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10

    Time frame: Day 10 (0 to 12 hours)

    CLr of PF-07817883 was reported in this outcome measure. CLr was calculated as Aetau/AUCtau.

  27. Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition

    Time frame: 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 tablet formulations under fed and fasted conditions were reported in statistical analysis.

  28. Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition

    Time frame: 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 tablet formulation under fed and fasted conditions were reported in statistical analysis.

  29. Part 3: Time for Cmax (Tmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Tmax of PF-07817883 was reported in this outcome measure.

  30. Part 3: Maximum Observed Concentration (Cmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Cmax of PF-07817883 was reported in this outcome measure.

  31. Part 3: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

  32. Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    AUCinf of PF-07817883 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.

  33. Part 3: Terminal Half-Life (t1/2) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

  34. Part 3: Apparent Clearance (CL/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

  35. Part 3: Apparent Volume of Distribution (Vz/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)

    Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).

  36. Part 3: Number of Participants With TEAEs

    Time frame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 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.

  37. Part 3: Number of Participants With Laboratory Test Abnormalities

    Time frame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)

    Laboratory parameters included: hematology (monocytes/leukocytes >1.2*ULN [%], partial thromboplastin time >1.1*ULN [seconds]) and urinalysis (urine hemoglobin >=1, bacteria >20 [/lpf]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.

  38. Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: Up to Day 3 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. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.

  39. Part 3: Number of Participants With ECG Abnormalities

    Time frame: Up to Day 3 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.

  40. Part 4: Time for Cmax (Tmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Tmax of PF-07817883 was reported in this outcome measure.

  41. Part 4: Maximum Observed Concentration (Cmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Cmax of PF-07817883 was reported in this outcome measure.

  42. Part 4: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

  43. Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    AUCinf of PF-07817883 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.

  44. Part 4: Terminal Half-Life (t1/2) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

  45. Part 4: Apparent Clearance (CL/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

  46. Part 4: Apparent Volume of Distribution (Vz/F) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)

    Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau*kel).

  47. Part 4: Number of Participants With TEAEs

    Time frame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 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.

  48. Part 4: Number of Participants With Laboratory Test Abnormalities

    Time frame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)

    Laboratory parameters included: hematology (mean corpuscular volume <0.9*LLN [cubic micrometer {um^3}], mean corpuscular hemoglobin <0.9*LLN [picograms per cell {pg/cell}], monocytes/leukocytes >1.2*ULN [%]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.

  49. Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: Up to Day 11

    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.

  50. Part 4: Number of Participants With ECG Abnormalities

    Time frame: Up to Day 11

    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.

  51. Part 5: Number of Participants With TEAEs

    Time frame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 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.

  52. Part 5: Number of Participants With Laboratory Test Abnormalities

    Time frame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)

    Laboratory parameters included: hematology (lymphocytes <0.8*LLN [10^3/mm3], lymphocytes/leukocytes <0.8*LLN [%], neutrophils/leukocytes <0.8*LLN [%], monocytes/leukocytes >1.2*ULN [%]), chemistry (amylase >1.5*ULN [units/liter] {U/L}), and urinalysis (urine hemoglobin >=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.

  53. Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria

    Time frame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)

    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.

  54. Part 5: Number of Participants With ECG Abnormalities

    Time frame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)

    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.

  55. Part 5: Time for Cmax (Tmax) of Midazolam

    Time frame: 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

    Tmax of midazolam was reported in this outcome measure.

  56. Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam

    Time frame: 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

    AUClast of midazolam was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

  57. Part 5: Terminal Half-Life (t1/2) of Midazolam

    Time frame: 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

    t1/2 of midazolam was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

  58. Part 5: Apparent Clearance (CL/F) of Midazolam

    Time frame: 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

    CL/F of midazolam was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

  59. Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam

    Time frame: 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

    Vz/F of midazolam was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf*kel).

  60. Part 6: Maximum Observed Concentration (Cmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)

    Cmax of PF-07817883 was reported in this outcome measure.

  61. Part 6: Time for Cmax (Tmax) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)

    Tmax of PF-07817883 was reported in this outcome measure.

  62. Part 6: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)

    AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

  63. Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)

    AUCinf of PF-07817883 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.

  64. Part 6: Terminal Half-Life (t1/2) of PF-07817883

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)

    t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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