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This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948 after administration of escalating, single, oral doses will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
|
| Cohort 2 | Experimental | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
|
| Cohort 3 | Experimental | Participants will receive up to 4 dose levels of PF-07328948 single dose and up to 2 single doses of matching placebo. Doses will be administered as oral suspensions and each dose level is to be determined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07328948 | Drug | investigational drug administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is 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 flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
| Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality | Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes <0.8 x lower limit of normal (LLN) or >1.2 x upper limit of normal (ULN); Neutrophils <0.8 x LLN; Neutrophils/Leukocytes <0.8 x LLN; Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; Bilirubin >1.5 x ULN; Indirect Bilirubin >1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) >20. | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
| Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria | Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration Observed in Plasma (Cmax) | Maximum observed plasma PF-07328948 concentration. Observed directly from data. | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
| Time to Achieve Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Receipt of a COVID-19 vaccine within 7 days before screening or within 7 days before any visit in which a safety lab is planned. Vaccination with a COVID 19 vaccine that occurs greater than 7 days from either screening or any visit in which a safety lab is planned is permitted.
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Renal impairment as defined by an eGFR <75 mL/min/1.73m2 calculated using CKD EPI SCr formulas.
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, STT interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate corrected using the Fridericia method only and the resulting QTcF should be used for decision-making and reporting.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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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 20 participants were enrolled, and received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| FG001 | PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| FG002 | PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| FG003 | Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| FG004 | PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo | Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.) |
| FG005 | Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg | Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.) |
| FG006 | PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| FG007 | PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| FG008 | PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| FG009 | Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| BG001 |
| 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 Reporting Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is 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 flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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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 | Placebo | Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| 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 | Jan 24, 2023 | Apr 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2023 | Apr 12, 2024 | SAP_001.pdf |
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| Placebo | Drug | Placebo matching active drug administered orally |
|
| Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
| Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria | ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
| Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate) | Maximum increase from baseline in ECG Mean Heart Rate was reported. | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
| Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval) | Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported. | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
Observed directly from data as time of first occurrence. |
| Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method. | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration. | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
| Terminal Half-Life (t1/2) of PF-07328948 | Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is 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 will be used in the regression. | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
| Withdrawal by Subject |
|
| Other |
|
| PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg |
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| BG002 | PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| BG003 | Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg | Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg). |
| BG004 | PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo | Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.) |
| BG005 | Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg | Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.) |
| BG006 | PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| BG007 | PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| BG008 | PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| BG009 | Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed) | Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg [fed]; Sequence: 300 mg, 750 mg, placebo, 750 mg [fed]; Sequence: 300 mg, placebo, 1500 mg, placebo [fed]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg [fed]). |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality | Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes <0.8 x lower limit of normal (LLN) or >1.2 x upper limit of normal (ULN); Neutrophils <0.8 x LLN; Neutrophils/Leukocytes <0.8 x LLN; Eosinophils/Leukocytes >1.2 x ULN; Monocytes/Leukocytes >1.2 x ULN; Bilirubin >1.5 x ULN; Indirect Bilirubin >1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) >20. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
|
|
|
| Primary | Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria | Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
|
|
|
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria | ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
|
|
|
| Primary | Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate) | Maximum increase from baseline in ECG Mean Heart Rate was reported. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Mean | Standard Deviation | bpm | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
|
|
|
| Secondary | Maximum Concentration Observed in Plasma (Cmax) | Maximum observed plasma PF-07328948 concentration. Observed directly from data. | 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 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
|
|
|
| Secondary | Time to Achieve Cmax (Tmax) | Observed directly from data as time of first occurrence. | 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 | hours (hr) | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method. | 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. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration. | 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. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
|
|
|
| Secondary | Terminal Half-Life (t1/2) of PF-07328948 | Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is 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 will be used in the regression. | 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. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM. | Posted | Mean | Standard Deviation | hours (hr) | Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4) |
|
|
|
| Primary | Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval) | Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Mean | Standard Deviation | msec | Day 1-8 per period, along with the 28-35 day post-final dose follow-up |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 3 |
| 13 |
| EG001 | Placebo (Fed) | Participants assigned to Cohort 3 received placebo (fed). | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | PF-07328948 10 mg | Participants assigned to Cohort 1 received PF-07328948 10 mg. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | PF-07328948 30 mg | Participants assigned to Cohort 1 received PF-07328948 30 mg. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG004 | PF-07328948 100 mg | Participants assigned to Cohort 1 received PF-07328948 100 mg. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | PF-07328948 300 mg | Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg. | 0 | 12 | 0 | 12 | 5 | 12 |
| EG006 | PF-07328948 750 mg | Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG007 | PF-07328948 750 mg (Fed) | Participants assigned to Cohort 3 received PF-07328948 750 mg (fed). | 0 | 5 | 0 | 5 | 1 | 5 |
| EG008 | PF-07328948 1500 mg | Participants assigned to Cohort 3 received PF-07328948 1500 mg. | 0 | 6 | 0 | 6 | 2 | 6 |
| Chest discomfort | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Change from baseline in SBP ≥30 mmHg decrease |
|
| Change from baseline in SBP ≥30 mmHg increase |
|
| DBP <50 mmHg |
|
| Change from baseline in DBP ≥20 decrease |
|
| Change from baseline in DBP ≥20 increase |
|
| Pulse rate < 40 bpm |
|
| Pulse rate > 120 bpm |
|
| %Change in PR interval ≥25/50% increase |
|
| QRS interval ≥140 msec |
|
| %Change in QRS interval ≥50% increase |
|
| QTcF interval >450 and ≤480 msec |
|
| QTcF interval >480 and ≤500 msec |
|
| QTcF interval >500 msec |
|
| Change in QTcF interval >30 and ≤60 msec |
|
| Change in QTcF interval >60 msec |
|
| Maximum increase from baseline in QRS Duration (msec) |
|
| Maximum increase from baseline in QTcF Interval (msec) |
|