A Phase 1 interventional study of Nirmatrelvir/ ritonavir and Nirmatrelvir/Ritonavir in Biological Availability, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rBA of the nirmatrelvir/ritonavir oral powder formulation. The study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nirmatrelvir and ritonavir tablets
Drug: Nirmatrelvir/ ritonavir
Nirmatrelvir/ritonavir with water
Drug: Nirmatrelvir/Ritonavir
Nirmatrelvir/ ritonavir with infant formula
Drug: Nirmatrelvir/Ritonavir
Nirmatrelvir/ ritonavir with vanilla pudding
Drug: Nirmatrelvir/ritonavir
Nirmatrelvir/ ritonavir with food and vanilla pudding
Drug: Nirmatrelvir/ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in water under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in infant formula under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fed condition
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Cmax was defined maximum observed concentration. Cmax for ritonavir 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir (under fasted/fed conditions) was calculated 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 after dose on Day 1 of Periods 4 and 5.
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir (under fasted/fed conditions) 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 after dose on Day 1 of Periods 4 and 5.
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir (under fasted/fed conditions) was calculated 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 after dose on Day 1 of Periods 4 and 5.
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
Cmax was defined maximum observed concentration. Cmax for ritonavir (under fasted/fed conditions) 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 after dose on Day 1 of Periods 4 and 5.
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study intervention and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting 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; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs included SAEs and all non-SAEs that occurred during the study.
Time frame: Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
The following laboratory test abnormalities (without regard to baseline abnormality) were reported during the study: monocytes/leukocytes (percentage \[%\]) is larger than (\>) 1.2x upper limit of normal (ULN), specific gravity (scalar) \>1.030, and urine hemoglobin was larger or equal to (\>=) 1.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days)
Number of Participants With Clinically Significant Vital Signs
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Vital signs were done predose, 2 hours and 6 hours post dose on Day 1 of each treatment period and also on Day 4 of Period 5. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days).
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant has rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days).
Number of Participants With Clinically Significant Physical Examination (PE) Values
A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Completed PE were performed by trained medical personnel at the investigator site at Screening or Period 1 Day 1 only. A brief PE might be performed at other designated time points at the discretion of the investigator. Clinical significance of physical examination values was determined at the investigator's discretion.
Time frame: Screening, Baseline up to Day 4 of Period 5 (approximately 20 days).
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
| Milestone | Treatment A->B->C->D->E | Treatment B->C->A->D->E | Treatment C->A->B->D->E | Treatment A->C->B->E->D | Treatment B->A->C->E->D | Treatment C->B->A->E->D |
|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 2 | 2 | 2 |
| Completed | 2 | 2 | 2 | 2 | 2 | 2 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
| nanogram*hour per milliliter (ng*hr/mL) | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 27090 ± 18 | 30650 ± 22 | 33030 ± 24 | 34000 ± 22 | 32810 ± 18 |
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated by linear/log trapezoidal method.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 26500 ± 20 | 30110 ± 23 | 32470 ± 25 | 33540 ± 22 | 32410 ± 19 |
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir was observed directly from data.
| ng/mL | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 2862 ± 20 | 3156 ± 26 | 4034 ± 23 | 4287 ± 22 | 4208 ± 23 |
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 4005 ± 37 | 3876 ± 34 | 3479 ± 40 | 3986 ± 34 | 3176 ± 30 |
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated by linear/log trapezoidal method.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3818 ± 38 | 3663 ± 35 | 3303 ± 40 | 3371 ± 49 | 2959 ± 32 |
Cmax was defined maximum observed concentration. Cmax for ritonavir was observed directly from data.
| ng/mL | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 398.4 ± 47 | 406.1 ± 46 | 368.1 ± 52 | 386.6 ± 66 | 280.7 ± 35 |
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 34000 ± 22 | 32810 ± 18 |
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 33540 ± 22 | 32410 ± 19 |
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir (under fasted/fed conditions) was observed directly from data.
| ng/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 4287 ± 22 | 4208 ± 23 |
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 3986 ± 34 | 3176 ± 30 |
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
| ng*hr/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 3371 ± 49 | 2959 ± 32 |
Cmax was defined maximum observed concentration. Cmax for ritonavir (under fasted/fed conditions) was observed directly from data.
| ng/mL | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|
| Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 386.6 ± 66 | 280.7 ± 35 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study intervention and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting 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; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs included SAEs and all non-SAEs that occurred during the study.
| Participants | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Participants with all-causality TEAEs | 2 | 4 | 5 | 2 | 2 |
| Participants with all-causality SAEs | 0 | 0 | 0 | 0 | 0 |
| Participants with treatment-related TEAEs | 2 | 3 | 1 | 1 | 1 |
| Participants with treatment-related SAEs | 0 | 0 | 0 | 0 | 0 |
The following laboratory test abnormalities (without regard to baseline abnormality) were reported during the study: monocytes/leukocytes (percentage \[%\]) is larger than (\>) 1.2x upper limit of normal (ULN), specific gravity (scalar) \>1.030, and urine hemoglobin was larger or equal to (\>=) 1.
| Participants | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Monocytes/Leukocytes (%) >1.2x ULN | 0 | 0 | 0 | 3 | 2 |
| Specific gravity (scalar) >1.030 | 0 | 0 | 0 | 1 | 0 |
| Urine hemoglobin >=1 | 0 | 0 | 0 | 2 | 1 |
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Vital signs were done predose, 2 hours and 6 hours post dose on Day 1 of each treatment period and also on Day 4 of Period 5. Clinical significance of vital signs was determined at the investigator's discretion.
| Participants | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Vital Signs | 0 | 0 | 0 | 0 | 0 |
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant has rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion.
| Participants | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 | 0 | 0 | 0 | 0 |
A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Completed PE were performed by trained medical personnel at the investigator site at Screening or Period 1 Day 1 only. A brief PE might be performed at other designated time points at the discretion of the investigator. Clinical significance of physical examination values was determined at the investigator's discretion.
| Participants | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 | 0 | 0 | 0 | 0 |
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
| Units on a scale | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) |
|---|---|---|---|
| 1 minute | 66.8 (54.08 to 79.42) | 65.4 (55.79 to 75.05) | 56.3 (46.17 to 66.50) |
| 5 minutes | 73.8 (62.36 to 85.14) | 60.3 (51.86 to 68.64) | 57.2 (48.16 to 66.17) |
| 10 minutes | 72.4 (61.34 to 83.49) | 59.3 (52.22 to 66.28) | 56.7 (46.44 to 66.89) |
| 20 minutes | 65.5 (55.87 to 75.13) | 56.3 (46.43 to 66.24) | 53.4 (43.30 to 63.54) |
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
| Units on a scale | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) |
|---|---|---|---|
| 1 minute | 75.3 (62.27 to 88.23) | 72.0 (63.22 to 80.78) | 61.4 (51.35 to 71.49) |
| 5 minutes | 75.4 (65.00 to 85.83) | 66.5 (59.09 to 73.91) | 58.2 (50.21 to 66.12) |
| 10 minutes | 72.1 (62.72 to 81.44) | 56.8 (47.15 to 66.35) | 56.8 (46.59 to 67.08) |
| 20 minutes | 66.2 (56.47 to 75.86) | 57.0 (48.14 to 65.86) | 55.4 (43.97 to 66.86) |
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
| Units on a scale | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) |
|---|---|---|---|
| 1 minute | 31.3 (17.50 to 45.00) | 36.3 (20.15 to 52.52) | 32.4 (16.58 to 48.25) |
| 5 minutes | 33.9 (18.74 to 49.09) | 29.9 (16.51 to 43.32) | 29.8 (14.73 to 44.93) |
| 10 minutes | 36.3 (19.61 to 52.89) | 29.7 (17.17 to 42.17) | 29.7 (15.83 to 43.50) |
| 20 minutes | 31.0 (17.22 to 44.78) | 25.8 (12.18 to 39.49) | 26.7 (13.46 to 39.87) |
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
| Units on a scale | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) |
|---|---|---|---|
| 1 minute | 30.9 (17.52 to 44.31) | 31.7 (15.42 to 47.92) | 26.4 (12.35 to 40.48) |
| 5 minutes | 34.5 (18.32 to 50.68) | 37.5 (21.44 to 53.56) | 27.3 (12.56 to 41.94) |
| 10 minutes | 34.4 (18.62 to 50.21) | 34.8 (17.90 to 51.60) | 29.4 (15.89 to 42.95) |
| 20 minutes | 33.7 (18.90 to 48.43) | 31.3 (16.10 to 46.40) | 27.8 (13.96 to 41.54) |
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
| Units on a scale | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) |
|---|---|---|---|
| 1 minute | 73.5 (62.24 to 84.76) | 65.0 (53.60 to 76.40) | 55.8 (45.43 to 66.24) |
| 5 minutes | 74.7 (64.19 to 85.15) | 66.3 (54.81 to 77.69) | 55.9 (46.29 to 65.54) |
| 10 minutes | 72.6 (63.09 to 82.08) | 62.4 (53.45 to 71.39) | 57.1 (47.06 to 67.11) |
| 20 minutes | 64.7 (51.68 to 77.66) | 56.4 (42.48 to 70.35) | 56.3 (46.25 to 66.42) |
Collected over Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) |
|---|---|---|---|---|---|
| Dry skinSkin and subcutaneous tissue disorders | 0/12 | 1/12 | 2/12 | 0/12 | 0/12 |
| Cerumen impactionEar and labyrinth disorders | 0/12 | 1/12 | 0/12 | 0/12 | 0/12 |
| ConstipationGastrointestinal disorders | 0/12 | 0/12 | 1/12 | 0/12 | 0/12 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/12 | 1/12 | 0/12 | 0/12 | 0/12 |
| Lip dryGastrointestinal disorders | 0/12 | 1/12 | 0/12 | 0/12 | 0/12 |
| NauseaGastrointestinal disorders | 0/12 | 1/12 | 0/12 | 0/12 | 0/12 |
| Oral disorderGastrointestinal disorders | 1/12 | 0/12 | 0/12 | 0/12 | 0/12 |
| FatigueGeneral disorders | 0/12 | 0/12 | 0/12 | 0/12 | 1/12 |
| Vessel puncture site haematomaGeneral disorders | 0/12 | 0/12 | 1/12 | 0/12 | 1/12 |
| Vessel puncture site painGeneral disorders | 0/12 | 0/12 | 1/12 | 0/12 | 0/12 |
All participants who were enrolled in this study.
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean (SD) | 47.2 ± 8.88 |
| Age, Customized(Participants) | All Participants |
|---|---|
| 18-44 Years | 4 |
| 45-64 Years | 8 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 1 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | All Participants |
|---|---|
| White | 10 |
| Black or African American | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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