Bioavailability
Conditions
Keywords
coronavirus disease 2019 (COVID-19), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir
Brief summary
The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.
Interventions
Single oral dose of PF-07321332/ritonavir under fasted conditions
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
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Exclusion criteria
* Positive test result 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 arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, 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 B surface antibody (HCVAb). Hepatitis B vaccination is allowed. * 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. * Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period. * A positive urine drug test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis. |
| AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method. |
| Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data. |
| AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis. |
| AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method. |
| Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. |
| Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. |
| Number of Participants With Treatment-Emergent Adverse Event | Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks. | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator. |
| Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. |
| Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. |
| Number of Participants With Laboratory Abnormalities | Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation. | Participants analyzed in the laboratory abnormalities were with at least one observation of the given laboratory test while on study treatment or during lag time. Number of participants with laboratory abnormalities were number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time. Hematology, chemistry, urinalysis and other (SARS-CoV-2 RT-PCR, Urine drug screening, Pregnancy test (β hCG), eGFR \[CKD-EPI\], aPTT, PT-INR, Fibrinogen, At Screening only: FSH, HBsAg, HBsAb, HBcAb, HCVAb, HIV) were assessed. |
| Number of Participants With Clinically Significant Vital Sign Values | Screening, Day 1 of each period and early termination/discontinuation. | Participants with clinically significant vital sign values were with at least one observation of vital signs, which met pre-specified criteria while on study treatment or during lag time. |
| Number of Participants With Clinically Significant Physical Examination Values | Screening and Period 1 Day -1. | Participants with clinically significant physical examination values were with at least one observation of physical examination, which met pre-specified criteria while on study treatment or during lag time. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | Screening, Period 1 Day 1 and Period 4 Day 4. | Participants with clinically significant electrocardiogram (ECG) values were with at least one observation of ECG, which met pre-specified criteria while on study treatment or during lag time. |
| Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. |
Countries
United States
Participant flow
Pre-assignment details
This was a phase 1, open label, single dose, randomized, crossover study in healthy adult participants. A total of 12 participants were assigned to the study, participating in 4 study periods to receive 4 different treatments, and 11 participants completed the study and 1 participant discontinued from the study intervention due to family emergency.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants enrolled in the study. | 12 |
| All Participants All participants enrolled in the study. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Other: family emergency. | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.25 Years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 6 / 11 | 2 / 11 | 1 / 12 | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 11 |
Outcome results
Primary
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 28670 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 36 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 30780 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 25 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 33170 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 33 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 36020 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 27 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [99.66, 115.64]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [112.09, 130.03]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [116.08, 134.69]
Primary
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4843 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 5414 ng*hr/mL | Geometric Coefficient of Variation 30 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4979 ng*hr/mL | Geometric Coefficient of Variation 45 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 5271 ng*hr/mL | Geometric Coefficient of Variation 26 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [95.38, 128.82]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [91.76, 123.73]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [92.7, 125.21]
Primary
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 27790 ng*hr/mL | Geometric Coefficient of Variation 36 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 30230 ng*hr/mL | Geometric Coefficient of Variation 27 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 32180 ng*hr/mL | Geometric Coefficient of Variation 33 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 35580 ng*hr/mL | Geometric Coefficient of Variation 27 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [101.06, 117.14]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [112.36, 130.2]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [118.32, 137.15]
Primary
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4588 ng*hr/mL | Geometric Coefficient of Variation 29 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 5108 ng*hr/mL | Geometric Coefficient of Variation 32 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4757 ng*hr/mL | Geometric Coefficient of Variation 46 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4998 ng*hr/mL | Geometric Coefficient of Variation 26 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [94.51, 128.47]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [92, 124.86]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [92.48, 125.72]
Primary
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Maximum plasma concentration (Cmax) was measured. Cmax 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, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 2817 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 3254 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 23 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4025 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 4572 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [104.03, 127.34]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [131.68, 160.99]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [145.95, 178.66]
Primary
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Maximum plasma concentration (Cmax) was measured. Cmax 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, 48 and 72 hours post-dose on Day 1 of each period
Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 536.9 ng/mL | Geometric Coefficient of Variation 41 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 598.2 ng/mL | Geometric Coefficient of Variation 42 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 579.8 ng/mL | Geometric Coefficient of Variation 45 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | 640.5 ng/mL | Geometric Coefficient of Variation 30 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water90% CI: [89.32, 132.32]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce90% CI: [90.05, 133]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding90% CI: [96.37, 142.77]
Secondary
Number of Participants With Clinically Significant Abnormal Electrocardiogram Values
Participants with clinically significant electrocardiogram (ECG) values were with at least one observation of ECG, which met pre-specified criteria while on study treatment or during lag time.
Time frame: Screening, Period 1 Day 1 and Period 4 Day 4.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examination Values
Participants with clinically significant physical examination values were with at least one observation of physical examination, which met pre-specified criteria while on study treatment or during lag time.
Time frame: Screening and Period 1 Day -1.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Clinically Significant Physical Examination Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Clinically Significant Physical Examination Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Clinically Significant Physical Examination Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Clinically Significant Physical Examination Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Values
Participants with clinically significant vital sign values were with at least one observation of vital signs, which met pre-specified criteria while on study treatment or during lag time.
Time frame: Screening, Day 1 of each period and early termination/discontinuation.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities
Participants analyzed in the laboratory abnormalities were with at least one observation of the given laboratory test while on study treatment or during lag time. Number of participants with laboratory abnormalities were number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time. Hematology, chemistry, urinalysis and other (SARS-CoV-2 RT-PCR, Urine drug screening, Pregnancy test (β hCG), eGFR \[CKD-EPI\], aPTT, PT-INR, Fibrinogen, At Screening only: FSH, HBsAg, HBsAb, HBcAb, HCVAb, HIV) were assessed.
Time frame: Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation.
Population: All participants who took at least 1 dose of study intervention were included in the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Laboratory Abnormalities | Urinalysis: pH (>8) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Laboratory Abnormalities | Urinalysis: Leukocyte Esterase (≥1) | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Laboratory Abnormalities | Urinalysis: Urine hemoglobin (≥1) | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Laboratory Abnormalities | Urinalysis: Nitrite (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Laboratory Abnormalities | Urinalysis: Nitrite (≥1) | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Laboratory Abnormalities | Urinalysis: Urine hemoglobin (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Laboratory Abnormalities | Urinalysis: Leukocyte Esterase (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Laboratory Abnormalities | Urinalysis: pH (>8) | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Laboratory Abnormalities | Urinalysis: Urine hemoglobin (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Laboratory Abnormalities | Urinalysis: Leukocyte Esterase (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Laboratory Abnormalities | Urinalysis: pH (>8) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Laboratory Abnormalities | Urinalysis: Nitrite (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Laboratory Abnormalities | Urinalysis: Leukocyte Esterase (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Laboratory Abnormalities | Urinalysis: pH (>8) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Laboratory Abnormalities | Urinalysis: Nitrite (≥1) | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Laboratory Abnormalities | Urinalysis: Urine hemoglobin (≥1) | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Event
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator.
Time frame: Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related TEAEs | 3 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Number of Participants With Treatment-Emergent Adverse Event | All-causality TEAEs | 6 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Treatment-Emergent Adverse Event | All-causality TEAEs | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related TEAEs | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Treatment-Emergent Adverse Event | All-causality TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Number of Participants With Treatment-Emergent Adverse Event | All-causality TEAEs | 4 Participants |
Secondary
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 69.8 Units on a scale | Standard Deviation 31.47 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 73.4 Units on a scale | Standard Deviation 32.39 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 75.4 Units on a scale | Standard Deviation 27.37 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 76.4 Units on a scale | Standard Deviation 29.15 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 67.3 Units on a scale | Standard Deviation 35.16 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 65.0 Units on a scale | Standard Deviation 35.46 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 64.7 Units on a scale | Standard Deviation 34.15 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 69.3 Units on a scale | Standard Deviation 34.39 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 61.4 Units on a scale | Standard Deviation 38.49 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 63.2 Units on a scale | Standard Deviation 33.48 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 63.2 Units on a scale | Standard Deviation 34.91 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 64.6 Units on a scale | Standard Deviation 37.72 |
Secondary
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 61.3 Units on a scale | Standard Deviation 31.25 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 63.2 Units on a scale | Standard Deviation 36.52 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 61.2 Units on a scale | Standard Deviation 35.96 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 60.5 Units on a scale | Standard Deviation 35.06 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 55.2 Units on a scale | Standard Deviation 32.56 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 53.5 Units on a scale | Standard Deviation 28.42 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 52.5 Units on a scale | Standard Deviation 38.92 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 52.0 Units on a scale | Standard Deviation 37.26 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 51.6 Units on a scale | Standard Deviation 37.29 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 57.5 Units on a scale | Standard Deviation 34.18 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 49.5 Units on a scale | Standard Deviation 31.3 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 48.5 Units on a scale | Standard Deviation 35.41 |
Secondary
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 77.9 Units on a scale | Standard Deviation 28.53 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 75.2 Units on a scale | Standard Deviation 32.14 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 78.2 Units on a scale | Standard Deviation 30.28 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 77.9 Units on a scale | Standard Deviation 30.83 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 67.0 Units on a scale | Standard Deviation 34.27 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 67.5 Units on a scale | Standard Deviation 37.16 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 65.0 Units on a scale | Standard Deviation 35.98 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 62.5 Units on a scale | Standard Deviation 33.89 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 63.9 Units on a scale | Standard Deviation 40.19 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 61.8 Units on a scale | Standard Deviation 34.69 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 66.5 Units on a scale | Standard Deviation 38.34 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 64.6 Units on a scale | Standard Deviation 38.99 |
Secondary
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 37.4 Units on a scale | Standard Deviation 29.85 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 42.6 Units on a scale | Standard Deviation 32.04 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 40.7 Units on a scale | Standard Deviation 31.09 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 40.5 Units on a scale | Standard Deviation 33.32 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 32.5 Units on a scale | Standard Deviation 29.41 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 34.6 Units on a scale | Standard Deviation 32.15 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 30.7 Units on a scale | Standard Deviation 29.63 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 29.7 Units on a scale | Standard Deviation 29.61 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 40.3 Units on a scale | Standard Deviation 35.7 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 34.9 Units on a scale | Standard Deviation 31.35 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 39.5 Units on a scale | Standard Deviation 38.53 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 27.6 Units on a scale | Standard Deviation 24.17 |
Secondary
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 42.5 Units on a scale | Standard Deviation 28.18 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 45.5 Units on a scale | Standard Deviation 34.74 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 43.7 Units on a scale | Standard Deviation 33.07 |
| Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 42.6 Units on a scale | Standard Deviation 35.5 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 33.8 Units on a scale | Standard Deviation 30.76 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 38.7 Units on a scale | Standard Deviation 30.57 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 32.4 Units on a scale | Standard Deviation 30.46 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 35.3 Units on a scale | Standard Deviation 30.52 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20min | 36.6 Units on a scale | Standard Deviation 31.5 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 min | 35.0 Units on a scale | Standard Deviation 31.38 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 min | 37.6 Units on a scale | Standard Deviation 36.98 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 min | 31.2 Units on a scale | Standard Deviation 28.69 |