Healthy Participants
Conditions
Keywords
food effect, COVID-19 (Coronavirus disease 2019), SARS-CoV (severe acute respiratory syndrome coronavirus)
Brief summary
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.
Interventions
Single oral dose of PF-07321332 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1
DRUGRitonavir
Single oral dose of ritonavir 100 mg at -12 hours prior to PF-07321332/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours after PF-07321332/ritonavir dosing.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. Female participants of childbearing potential must have a negative pregnancy test. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
Exclusion criteria
* Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of Screening or Day -1. * 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). * Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy- or brady brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure, underlying structural heart disease, Wolff Parkinson-White syndrome). * Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. * 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 (eg,. contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 | 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 | 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. |
| Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 | 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 | 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. |
| Maximum Observed Plasma Concentration (Cmax) of PF-07321332 | 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 | Cmax was defined as maximum observed plasma concentration. It was observed directly from data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vz/F) of PF-07321332 | 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 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days) | 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. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 | 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 | Tmax was defined as the time to reach maximum observed plasma concentration of PF-07321332. |
| Number of Participants Meeting Pre-Specified Criteria for Vital Signs | Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days) | 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. |
| Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values | Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days) | 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%. |
| Number of Participants With Clinical Laboratory Abnormalities | Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days) | 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. |
| Terminal Elimination Half-life (t1/2) of PF-07321332 | 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 | 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. |
| Apparent Clearance (CL/F) of PF-07321332 From Plasma | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 12 healthy participants signed the informed consent form (ICF) and were enrolled in the study. All of them received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| PF-07321332 Fasted + Ritonavir Then PF-07321332 Fed + Ritonavir Period 1: Participants received a single oral dose of PF-07321332 300 mg (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions in Period 1 and serial PK samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug. | 6 |
| PF-07321332 Fed + Ritonavir Then PF-07321332 Fasted + Ritonavir Period 1: Participants received a single oral dose of PF-07321332 300 mg (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions in Period 1 and serial PK samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1) , 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | PF-07321332 Fed + Ritonavir Then PF-07321332 Fasted + Ritonavir | Total | PF-07321332 Fasted + Ritonavir Then PF-07321332 Fed + Ritonavir |
|---|---|---|---|
| Age, Continuous | 40.2 Years STANDARD_DEVIATION 13.03 | 46.9 Years STANDARD_DEVIATION 14.3 | 53.7 Years STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 6 / 12 | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 | 44050 Nanogram*hour per milliliter | Geometric Coefficient of Variation 31 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 | 36810 Nanogram*hour per milliliter | Geometric Coefficient of Variation 36 |
90% CI: [108.75, 131.68]
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 | 43360 Nanogram*hour per milliliter | Geometric Coefficient of Variation 31 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 | 35860 Nanogram*hour per milliliter | Geometric Coefficient of Variation 35 |
90% CI: [109.3, 133.74]
Primary
Maximum Observed Plasma Concentration (Cmax) of PF-07321332
Cmax was defined as maximum observed plasma concentration. It was observed directly from data.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Maximum Observed Plasma Concentration (Cmax) of PF-07321332 | 5951 Nanogram per milliliter | Geometric Coefficient of Variation 31 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Maximum Observed Plasma Concentration (Cmax) of PF-07321332 | 3696 Nanogram per milliliter | Geometric Coefficient of Variation 44 |
90% CI: [139.05, 186.44]
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Apparent Clearance (CL/F) of PF-07321332 From Plasma | 6.812 Liters per hour | Geometric Coefficient of Variation 31 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Apparent Clearance (CL/F) of PF-07321332 From Plasma | 8.148 Liters per hour | Geometric Coefficient of Variation 36 |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Apparent Volume of Distribution (Vz/F) of PF-07321332 | 68.77 Liters | Geometric Coefficient of Variation 41 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Apparent Volume of Distribution (Vz/F) of PF-07321332 | 96.88 Liters | Geometric Coefficient of Variation 38 |
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%.
Time frame: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
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.
Time frame: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Number of Participants Meeting Pre-Specified Criteria for Vital Signs | 0 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Number of Participants Meeting Pre-Specified Criteria for Vital Signs | 0 Participants |
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.
Time frame: Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days)
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Number of Participants With Clinical Laboratory Abnormalities | 4 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Number of Participants With Clinical Laboratory Abnormalities | 4 Participants |
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.
Time frame: Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 6 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 5 Participants |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Terminal Elimination Half-life (t1/2) of PF-07321332 | 7.390 Hours | Standard Deviation 2.5843 |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Terminal Elimination Half-life (t1/2) of PF-07321332 | 8.673 Hours | Standard Deviation 3.3768 |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg/Ritonavir 100 mg Fed | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 | 2.50 Hours |
| PF-07321332 300 mg/Ritonavir 100 mg Fasted | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 | 2.29 Hours |