AzTrials
AzTrials

HealthyPhase 1NCT05580003

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

A Phase 1 study testing PF-07817883, Midazolam and Moxifloxacin in people with Healthy, run by Pfizer at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07817883, Midazolam and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
2 sitesin 2 countries
Study dates
17 Oct 2022to 15 Sep 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
PF-07817883, Placebo, Midazolam, Moxifloxacin
Keywords
Oral Antiviral, COVID-19, Protease Inhibitor, Mpro, PF-07817883
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07817883Drug

    Oral suspension or solid oral formulation(s)

  • PlaceboDrug

    Placebo suspension

  • MidazolamDrug

    midazolam oral solution

  • MoxifloxacinDrug

    Moxifloxacin 400 mg tablet

Study groups in NCT05580003
Study groupRoleWhat they receive
PF-07817883 Dose 1 in PART-1ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 Dose 2 in PART-1ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 Dose 3 in PART-1ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 Dose 4 in PART-1ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 Dose 5 in PART-1ExperimentalOptional dose levels
Receives: Drug: PF-07817883
PF-07817883 Dose 6 in PART-1ExperimentalOptional dose levels
Receives: Drug: PF-07817883
Placebo in PART-1Placebo comparatorA single dose of placebo
Receives: Drug: Placebo
PF-07817883 DR1 in PART-2ExperimentalDR=Dosing regimen; twice a day
Receives: Drug: PF-07817883
PF-07817883 DR2 in PART-2ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 DR3 in PART-2ExperimentalOptional dosing regimen
Receives: Drug: PF-07817883
PF-07817883 DR4 in PART-2ExperimentalOptional dosing regimen
Receives: Drug: PF-07817883
PF-07817883 in Japanese in PART-2ExperimentalOptional dosing regimen to be studied in Japanese population
Receives: Drug: PF-07817883
PF-07817883 in Chinese in PART-2ExperimentalOptional dosing regimen to be studied in Chinese population
Receives: Drug: PF-07817883
Placebo in PART-2Placebo comparatorNot described
Receives: Drug: Placebo
PF-07817883 Suspension Fasted in PART-3ExperimentalPART-3 is optional
Receives: Drug: PF-07817883
PF-07817883 FORM-1 Fasted in PART-3ExperimentalFirst solid oral formulation (FORM1)
Receives: Drug: PF-07817883
PF-07817883 FORM-2 Fasted in PART-3ExperimentalSecond solid oral formulations (FORM-2) is optional
Receives: Drug: PF-07817883
PF-07817883 FORM-1 Fed in PART-3ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 FORM-2 Fed in PART-3ExperimentalNot described
Receives: Drug: PF-07817883
PF-07817883 in PART-4ExperimentalPART-4 is optional
Receives: Drug: PF-07817883
Midazolam 5 mg in PART-5ExperimentalSingle dose of 5 mg alone
Receives: Drug: Midazolam
Midazolam 5 mg with PF-07817883 in PART-5ExperimentalSingle dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883
Receives: Drug: PF-07817883; Drug: Midazolam
PF-07817883 in PART-6ExperimentalA single dose at supratherapeutic exposure administered as divided doses (1h apart)
Receives: Drug: PF-07817883
Placebo in PART-6Placebo comparatorA single dose of placebo administered as divided doses (1h apart)
Receives: Drug: Placebo
Moxifloxacin 400 mg in PART-6 (open label)Active comparatorMoxifloxacin 400 mg at 0h followed by placebo at 1h
Receives: Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)

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

    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.

    Measured: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)

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

    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.

    Measured: Up to Day 2 of each period

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

    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.

    Measured: Up to Day 2 of each period

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

    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.

    Measured: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)

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

    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.

    Measured: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)

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

    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.

    Measured: Up to Day 12

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

    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.

    Measured: Up to Day 12

  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

    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.

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

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

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

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

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

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

    Measured: Up to 144 hours post-dose

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

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

    Measured: Up to 144 hours post-dose

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

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

    Measured: Up to 144 hours post-dose

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

    Cmax of midazolam was reported in this outcome measure.

    Measured: 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

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

    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.

    Measured: 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

  16. Part 6: Number of Participants With TEAEs

    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.

    Measured: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)

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

    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.

    Measured: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)

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

    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.

    Measured: Up to Day 6 of each period

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

    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.

    Measured: Up to Day 6 of each period

Secondary outcomes (64)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

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

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

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

    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.

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

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

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

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

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

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

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

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

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

    Measured: 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)

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

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

    Measured: 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)

  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

    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.

    Measured: 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)

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

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

    Measured: 12 hours on Day 5 and Day 10

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

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

    Measured: 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)

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

    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.

    Measured: 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)

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

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

    Measured: 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)

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

    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.

    Measured: 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)

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

    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.

    Measured: 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)

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

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

    Measured: 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)

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

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

    Measured: 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)

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

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

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

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

    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.

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

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

    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.

    Measured: Day 10 (0 to 12 hours)

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

    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.

    Measured: Day 10 (0 to 12 hours)

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

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

    Measured: Day 10 (0 to 12 hours)

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

    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.

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

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

    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.

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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

  36. Part 3: Number of Participants With TEAEs

    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.

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

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

    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.

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

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

    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.

    Measured: Up to Day 3 of each period

  39. Part 3: Number of Participants With ECG Abnormalities

    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.

    Measured: Up to Day 3 of each period

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

  47. Part 4: Number of Participants With TEAEs

    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.

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

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

    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.

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

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

    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.

    Measured: Up to Day 11

  50. Part 4: Number of Participants With ECG Abnormalities

    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.

    Measured: Up to Day 11

  51. Part 5: Number of Participants With TEAEs

    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.

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

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

    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.

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

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

    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.

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

  54. Part 5: Number of Participants With ECG Abnormalities

    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.

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

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

    Tmax of midazolam was reported in this outcome measure.

    Measured: 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

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

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

    Measured: 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

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

    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.

    Measured: 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

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

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

    Measured: 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

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

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

    Measured: 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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start17 Oct 2022
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580003
Sponsor's protocol ID
C5091001
Other IDs
2022-002871-12, 2022-002871-12
Status last verified
Sep 2024
First submitted
11 Oct 2022
Last updated
21 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Singh RSP, Toussi SS, Hackman F, Shahbazi M, Prybylski J, Sahasrabudhe SA, Crownover P, Kadar EP, George BT, Alami NN, Bergman A. A Multipart Phase 1 Study to Assess Safety and Pharmacokinetics of Ibuzatrelvir in Healthy Participants and Dose Selection for a Dose-Ranging Study. Clin Transl Sci. 2026 Jul;19(7):e70659. doi: 10.1111/cts.70659.

    PubMed 42433209

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07817883, Midazolam and Moxifloxacin in people with Healthy, run by Pfizer at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in