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The purpose of the study is to evaluate the effect of a low-fat and high-fat meal on the medicine called PF-07284890 following three single doses PF-07284890. The study will include male participants and female participants of non-childbearing potential who are healthy. Participants will be required to stay in the clinical research unit for 15 days and 14 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07284890 Sequence 1 | Experimental | PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. |
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| PF-07284890 Sequence 2 | Experimental | PF-07284890 tablet will be taken by mouth for Treatment B after a low fat meal. Five days later PF-07284890 tablet will be taken by mouth in a single dose for Treatment A while fasting. Five days later PF-07284890 tablet will be taken by mouth for Treatment C after a high fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07284890 Treatment A | Drug | PF-07284890 tablet by mouth while fasting |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
| Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
| AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition | AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Cmax (Tmax) of PF-07284890 in Plasma | Tmax was defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07284890 200 mg Fasted=>PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg High-fat Meal | Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days. |
| FG001 | PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg Fasted=>PF-07284890 200 mg High-fat Meal | Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (5 Days) |
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| Period 2 (5 Days) |
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| Period 3 (5 Days) |
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Baseline analysis population included all participants assigned to the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Female | The Female participant was a healthy adult of non-childbearing potential between 18-65 years of age. |
| BG001 | Male | Male participants were healthy adults between 18-65 years of age. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*Hour per Milliliter (ng*hr/mL) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
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From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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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-07284890 200 mg Fasted in Period 1 (Sequence 1) | Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v25.0 | 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 | Apr 6, 2022 | Aug 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2022 | Aug 17, 2023 | SAP_001.pdf |
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| PF-07284890 Treatment B | Drug | PF-07284890 tablet after low fat meal |
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| PF-07284890 Treatment C | Drug | PF-07284890 tablet after high fat meal |
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AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. |
| 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma |
t1/2 was defined as the time required for the plasma concentration to decline by 50% during the elimination phase. t1/2 = loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. |
| 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| Apparent Clearance (CL/F) of PF-07284890 in Plasma | CL/F was defined as the apparent clearance. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL/F = dose/AUCinf, where AUCinf was the area under the plasma concentration-time curve from time zero extrapolated to infinity. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma | Vz/F was defined as the apparent volume of distribution for extravascular dosing. Determination method of Vz/F was dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as 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. Any events occurring following start of treatment were considered as TEAEs. | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
| Number of Participants With Clinical Laboratory Abnormalities | The hematological (Lymphocytes/Leukocytes, Neutrophils/Leukocytes and Monocytes/Leukocytes), clinical chemistry (Urate and Potassium) and urinalysis (Urine Hemoglobin, Leukocyte Esterase and Bacteria) safety tests were assessed against the pre-specified criteria. The assessment did not take into account whether each participant's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter. | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
| Number of Participants With Pre-Specified Categorization Criteria for Vital Signs | Supine systolic/diastolic blood pressure (BP) and pulse rate (PR) were measured and evaluated against pre-specified categorization criteria. The criteria included change of supine systolic/diastolic BP >=30 mmHg increase or decrease, and value of supine PR >120 beats per minute (bpm). | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
| Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs) | Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measured PR interval, QT interval, corrected QT interval using Fridericia's formula (QTcF), and time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) complex. The number of participants with PR/QRS values and percent change from baseline, QT interval values, and QTcF values and increases from baseline in the pre-specified categories were summarized in this outcome measure (OM). | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
| OG001 | PF-07284890 200 mg Fasted (Reference) | Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2. |
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| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
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| Primary | Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per Milliliter (ng/mL) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2 |
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|
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| Primary | AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition | AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
|
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| Primary | AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition | AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Primary | Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Secondary | Time to Reach Cmax (Tmax) of PF-07284890 in Plasma | Tmax was defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Median | Full Range | Hours (hr) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Secondary | Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma | t1/2 was defined as the time required for the plasma concentration to decline by 50% during the elimination phase. t1/2 = loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hr | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Secondary | Apparent Clearance (CL/F) of PF-07284890 in Plasma | CL/F was defined as the apparent clearance. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL/F = dose/AUCinf, where AUCinf was the area under the plasma concentration-time curve from time zero extrapolated to infinity. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per Hour (L/hr) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Secondary | Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma | Vz/F was defined as the apparent volume of distribution for extravascular dosing. Determination method of Vz/F was dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3 |
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| Secondary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as 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. Any events occurring following start of treatment were considered as TEAEs. | The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities | The hematological (Lymphocytes/Leukocytes, Neutrophils/Leukocytes and Monocytes/Leukocytes), clinical chemistry (Urate and Potassium) and urinalysis (Urine Hemoglobin, Leukocyte Esterase and Bacteria) safety tests were assessed against the pre-specified criteria. The assessment did not take into account whether each participant's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter. | The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed = number of participants evaluable for laboratory abnormalities. Number Analyzed = total number of participants with at least one observation of the given laboratory test. | Posted | Count of Participants | Participants | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
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| Secondary | Number of Participants With Pre-Specified Categorization Criteria for Vital Signs | Supine systolic/diastolic blood pressure (BP) and pulse rate (PR) were measured and evaluated against pre-specified categorization criteria. The criteria included change of supine systolic/diastolic BP >=30 mmHg increase or decrease, and value of supine PR >120 beats per minute (bpm). | The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
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| Secondary | Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs) | Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measured PR interval, QT interval, corrected QT interval using Fridericia's formula (QTcF), and time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) complex. The number of participants with PR/QRS values and percent change from baseline, QT interval values, and QTcF values and increases from baseline in the pre-specified categories were summarized in this outcome measure (OM). | The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | PF-07284890 200 mg Low-fat Meal in Period 1 (Sequence 2) | Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | PF-07284890 200 mg Low-fat Meal in Period 2 (Sequence 1) | Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 2. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | PF-07284890 200 mg Fasted in Period 2 (Sequence 2) | Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 2. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 1) | Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 2) | Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3. | 0 | 5 | 0 | 5 | 1 | 5 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Neutrophils/Leukocytes <0.8 x lower limit of normal (LLN) |
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| Monocytes/Leukocytes >1.2 x ULN |
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| Urate >1.2 x ULN |
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| Potassium >1.1 x ULN |
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| Urine Hemoglobin >=1 |
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| Leukocyte Esterase >=1 |
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| Bacteria >20 |
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| Change of Supine Diastolic BP >=20 mmHg Increase |
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| Change of Supine Diastolic BP >=20 mmHg Decrease |
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| Value of Supine PR >120 bpm |
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| Value of QRS Duration >=140 msec |
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| Percent Change of QRS Duration >=50% |
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| Value of QT Interval >=500 msec |
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| Value of QTcF >450 msec and <=480 msec |
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| Value of QTcF >480 msec and <=500 msec |
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| Value of QTcF >500 msec |
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| Change of QTcF >=30 msec and <=60 msec |
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| Change of QTcF >60 msec |
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