| Primary | Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 | Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration was determined by linear/log trapezoidal method and reported in this outcome measure. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00043360± 31
- OG00135860± 35
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Ratio of Adjusted Geometric Means | 120.90 | | | 2-Sided | 90 | 109.30 | 133.74 | | | Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages. | | Other | | |
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| Primary | Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 | AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast was the predicted plasma concentration at the last quantifiable time point 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. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of PF-07321332 | Cmax was defined as maximum observed plasma concentration. It was observed directly from data. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 | Tmax was defined as the time to reach maximum observed plasma concentration of PF-07321332. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | Hours | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Terminal Elimination Half-life (t1/2) of PF-07321332 | t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | Hours | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Apparent Clearance (CL/F) of PF-07321332 From Plasma | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent clearance) is influenced by the fraction of the dose absorbed. CL/F was calculated as dose/AUCinf. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Apparent Volume of Distribution (Vz/F) of PF-07321332 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F was calculated as dose/(AUCinf*kel). kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2 | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted 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. Treatment-emergent were events between first dose of study drug and up to maximum of 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days) | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted |
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities | Clinical laboratory abnormalities included following criteria: a) hematology evaluation included eosinophils/leukocytes greater than (>) 1.2* upper limit of normal (ULN), monocytes/leukocytes >1.2*ULN; b) clinical chemistry evaluation included urobilinogen greater than or equal to (>=) 1, fibrinogen >1.25*baseline; c) urinalysis evaluation included urine hemoglobin >=1. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days) | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Number of Participants Meeting Pre-Specified Criteria for Vital Signs | Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease >= 30 mmHg, max. increase >=30 mmHg; diastolic BP min. <50mmHg; diastolic BP change from baseline max. decrease >=20, max. increase >=20; supine pulse rate min. <40 beats per minute (bpm) and max. >120 bpm. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days) | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. |
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| Secondary | Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values | A 12-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. The pre specified criteria for ECG values included absolute value of QTCF (Fridericia's correction formula): >=450 to less than or equal to (<=) 480 milliseconds, >480 to <=500 milliseconds, >500 milliseconds, increase from baseline >30 - <=60, increase from baseline >60. PR interval: >=300 milliseconds, increase from baseline: baseline >200 milliseconds and max. increase >=25% and baseline <=200 milliseconds and max. increase >=50%; QRS duration: >=140 milliseconds, increase from baseline >=50%. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days) | | | | ID | Title | Description |
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| OG000 | PF-07321332 300 mg/Ritonavir 100 mg Fed | Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug. | | OG001 | PF-07321332 300 mg/Ritonavir 100 mg Fasted |
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