A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults

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.

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.

Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.

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.

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.

Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.

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.

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.

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.

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.

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 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.

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).

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).