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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504921-37-00 | Registry Identifier | CTIS (EU) |
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The purposes of the study are:
To learn about the safety and tolerability of study medicine (PF-07293893). Tolerability is the extent to which side effects can be tolerated. Side effects are unwanted reactions to the study medicine.
To measure the amount of PF-07293893 in blood after the medicine is taken by mouth.
The study is seeking participants who:
Participants will receive either PF-07293893 or placebo (dummy pill) by chance. Participants will undergo up to 4 treatments periods in this study. Everyone will receive up to 4 doses of study medicine and up to 2 doses of placebo. In each period, participants will stay in study clinic for 5 days. There will be at least 2 days between each treatment period.
Participants will be involved in this study for about 14 weeks. During their stay, participants will undergo several examinations. Participants will also have their blood collected by the study doctors for several times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07293893 and Placebo (Cohort 1) | Experimental | Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. |
|
| PF-07293893 and Placebo (Cohort 2) | Experimental | Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. |
|
| PF-07293893 and Placebo (Cohort 3) | Experimental | Single dose administration of PF-07293893 and placebo; Within a cohort, participants will receive up to 4 doses of PF-07293893 and up to 2 doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07293893 | Drug | PF-07293893 will be prepared as an oral suspension given in escalating single doses to be determined. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug. | Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days) |
| Number of Participants With Laboratory Test Abnormalities | Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported. | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
| Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion. | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion. | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of PF-07293893 | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period | |
| Time for Cmax (Tmax) of PF-07293893 | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
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This study is seeking participants who are:
This study is not seeking participants who have:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≥1.05 × upper limit of normal (ULN), participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 30 participants (initially randomized participants and replacement participants) were enrolled in this study. All participants received at least 1 dose of study intervention and were assigned in the study into 3 cohorts. As planned, there were "replacement" participants in the study who were not initially randomized, but they replaced those participants who discontinued in any treatment period due to reasons other than safety; this was per investigator's and sponsor's discretion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Sequence 1 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893. SDD = spray dried dispersion form. |
| FG001 | Cohort 1: Sequence 2 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg. |
| FG002 | Cohort 1: Sequence 3 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg. |
| FG003 | Cohort 1: Sequence 4 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg. |
| FG004 | Cohort 2: Sequence 1 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg. CRYS = crystalline form. |
| FG005 | Cohort 2: Sequence 2 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): placebo matched to PF-07293893; then Period 4/Day1 (CRYS, fed): placebo matched to PF-07293893. |
| FG006 | Cohort 2: Sequence 3 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (CRYS, fasted):PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg. |
| FG007 | Cohort 2: Sequence 4 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF 07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg. |
| FG008 | Cohort 3: Sequence 1 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg. |
| FG009 | Cohort 3: Sequence 2 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg. |
| FG010 | Cohort 3: Sequence 3 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg. |
| FG011 | Cohort 3: Sequence 4 | Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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Except the replacement participants, all participants were randomized to receive all interventions in a cohort. Thus, the participants in a cohort were combined in the record.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (10 mg, 30 mg, 100 mg or 300 mg) in sequence 1 or 2 or 3 or 4. |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug. | Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days) |
|
Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-07293893 10 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 10 mg in fasted condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
Any untoward findings identified on physical and/or neurological examinations, cardiac monitoring conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2023 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2024 | Mar 21, 2025 | SAP_001.pdf |
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| Placebo | Drug | Matching placebo will be prepared as an oral suspension given in each cohort. |
|
| Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893 | AUClast was calculated using linear/log trapezoidal method. | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
| Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893 | AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
| Terminal Half-Life (t1/2) of PF-07293893 | t1/2 was calculated as log^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (300mg [fast/fed],750 mg, 1500 mg) in sequence 1 or 2 or 3 or 4.
| BG002 | Cohort 3 | In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (750 mg [fast/fed], 900 mg, 1200 mg) in sequence 1 or 2 or 3 or 4. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | PF-07293893 30 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 30 mg in fasted condition. |
| OG002 | PF-07293893 100 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD100 mg in fasted condition. |
| OG003 | PF-07293893 300 mg: CRYS/Fasted Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fasted condition. |
| OG004 | PF-07293893 300 mg: CRYS/Fed Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fed condition. |
| OG005 | PF-07293893 300 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 300 mg in fasted condition. |
| OG006 | PF-07293893 750 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 750 mg in fasted condition. |
| OG007 | PF-07293893 750 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 750 mg in fasted condition. |
| OG008 | PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 | Participants who received PF-07293893 SDD 750 mg in fasted condition. |
| OG009 | PF-07293893 750 mg: SDD/Fed Cohort 3 | Participants received PF-07293893 SDD 750 mg in fed condition. |
| OG010 | PF-07293893 900 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 900 mg in fasted condition. |
| OG011 | PF-07293893 1200 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 1200 mg in fasted condition. |
| OG012 | PF-07293893 1500 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 1500 mg in fasted condition. |
| OG013 | Placebo: CRYS/Fasted Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fasted condition. |
| OG014 | Placebo: CRYS/Fed Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fed condition. |
| OG015 | Placebo: SDD/Fasted Combined for All Cohorts | Participants received placebo matched to PF-07293893 SDD in fasted condition. |
| OG016 | Placebo: SDD/Fed Cohort 2 | Participants received placebo matched to PF-07293893 SDD in fed condition. |
|
|
| Primary | Number of Participants With Laboratory Test Abnormalities | Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes <0.8*lower limit of normal [LLN], lymphocytes/leukocytes <0.8*LLN, neutrophils <0.8*LLN, neutrophils/leukocytes <0.8*LLN, eosinophils/leukocytes >1.2*upper limit of normal [ULN], monocytes >1.2*ULN, monocytes/leukocytes >1.2*ULN); clinical chemistry (aspartate aminotransferase >3.0*ULN, potassium >1.1*ULN, creatine kinase >2.0*ULN); urinalysis (urine specific gravity <1.003 ,>1.030, ketones >=1, urine hemoglobin >=1, urobilinogen >=1, urine bilirubin >=1, leukocyte esterase >=1). In this outcome measure, participants with any laboratory abnormalities are reported. | Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days) |
|
|
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| Secondary | Maximum Plasma Concentration (Cmax) of PF-07293893 | Pharmacokinetic (PK) parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ mL) | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
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| Secondary | Time for Cmax (Tmax) of PF-07293893 | PK parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. | Posted | Median | Full Range | Hour | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
|
|
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| Secondary | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893 | AUClast was calculated using linear/log trapezoidal method. | PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/ mL) | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893 | AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/ mL) | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
|
|
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| Secondary | Terminal Half-Life (t1/2) of PF-07293893 | t1/2 was calculated as log^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. | PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Mean | Standard Deviation | Hour | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment period |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | PF-07293893 30 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 30 mg in fasted condition. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | PF-07293893 100 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD100 mg in fasted condition. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | PF-07293893 300 mg: CRYS/Fasted Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fasted condition. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | PF-07293893 300 mg: CRYS/Fed Cohort 2 | Participants received PF-07293893 CRYS 300 mg in fed condition. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG005 | PF-07293893 300 mg: SDD/Fasted Cohort 1 | Participants received PF-07293893 SDD 300 mg in fasted condition. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | PF-07293893 750 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 750 mg in fasted condition. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG007 | PF-07293893 750 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 750 mg in fasted condition. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG008 | PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3 | Participants who received PF-07293893 SDD 750 mg in fasted condition. | 0 | 12 | 0 | 12 | 8 | 12 |
| EG009 | PF-07293893 750 mg: SDD/Fed Cohort 3 | Participants received PF-07293893 SDD 750 mg in fed condition. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG010 | PF-07293893 900 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 900 mg in fasted condition. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG011 | PF-07293893 1200 mg: SDD/Fasted Cohort 3 | Participants received PF-07293893 SDD 1200 mg in fasted condition. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG012 | PF-07293893 1500 mg: SDD/Fasted Cohort 2 | Participants received PF-07293893 SDD 1500 mg in fasted condition. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG013 | Placebo: CRYS/Fasted Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fasted condition. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG014 | Placebo: CRYS/Fed Cohort 2 | Participants received placebo matched to PF-07293893 CRYS in fed condition. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG015 | Placebo: SDD/Fasted Combined for All Cohorts | Participants received placebo matched to PF-07293893 SDD in fasted condition. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG016 | Placebo: SDD/Fed Cohort 2 | Participants received placebo matched to PF-07293893 SDD in fed condition. | 0 | 2 | 0 | 2 | 1 | 2 |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.