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The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07321332/ritonavir | Experimental | PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07321332/ritonavir | Drug | PF-07321332/ritonavir will be given by mouth two times a day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1 | Cmax is maximum plasma concentration . | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10 | Cmax is maximum plasma concentration | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 | Tmax is the time for maximum plasma concentration | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 | Tmax is the time for maximum plasma concentration | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 | Area under the plasma concentration-time profile from time Zero to time point on 12 hours | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42090083 | Derived | Li N, Yu J, Wu J, Zhang J, Ma Y, Zhang C, Han X, Gerhart J, Cong S. Pharmacokinetics of Nirmatrelvir/Ritonavir after Multiple Administration in a Phase 1, Open-Label Study in Healthy Chinese Adults and Compared with Non-Chinese Participants. Clin Drug Investig. 2026 Jul;46(7):783-793. doi: 10.1007/s40261-026-01554-y. Epub 2026 May 6. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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The study consisted of 1 treatment group: multiple oral doses of PF-07321332300 mg/ritonavir 100 mg. A total of 14 healthy participants were enrolled and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07321332 300 mg + Ritonavir 100 mg | The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-07321332 300 mg + Ritonavir 100 mg | The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1 | Cmax is maximum plasma concentration . | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
From baseline up to Day 42.
The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-07321332 300 mg + Ritonavir 100 mg | The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2021 | Apr 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2021 | Apr 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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This was determined by AUCtau/tau. |
| Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10 | Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1. | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10 | Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1. | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| PF-07321332 Peak-to-trough Ratio (PTR) on Day 10 | This was determined by Day 10 Cmax/Day 10 Ctrough. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Apparent Clearance (CL/F) on Day 10 | Apparent oral clearance. This was determined by Dose/AUCtau. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10 | Apparent oral volume of distribution. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| PF-07321332 Terminal Elimination Half-life (t½) on Day 10 | Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours) |
| PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours) |
| PF-07321332 Trough Concentration (Ctrough) on Day 5 | Concentration at pre-dose on Day 5. Observed directly from data. | Day 5 (pre-dose) |
| PF-07321332 Trough Concentration (Ctrough) on Day 8 | Concentration at pre-dose on Day 8. Observed directly from data. | Day 8 (pre-dose) |
| PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose) | Concentration at pre-dose on Day 10. Observed directly from data. | Day 10 (pre-dose) |
| PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) | Concentration at 12 hour time on Day 10. Observed directly from data. | Day 10 (12 hours after last dose) |
| From baseline up to Day 42 |
| Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria | Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease >= 30 mmHg, max. increase >=30 mmHg; diastolic BP min. <50mmHg; diastolic BP change from baseline max. decrease >=20, max. increase >=20; seated pulse rate min. <40 beats per minute (bpm) and max. >120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure. | Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose) |
| Number of Participants With Laboratory Abnormalities | Safety laboratory assessments included hematology, urinalysis, and clinical chemistry. | Day-1, Day 2, Day 5, Day 8, Day 10, Day 12. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds[msec]) >450 and ≤480, or >480 and ≤500, or >500; Increase from baseline in QTcF (msec) >30 and ≤60, or>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline >200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure. | Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose) |
| Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1 | Cmax is maximum plasma concentration | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10 | Cmax is maximum plasma concentration | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 | Tmax is the time for maximum plasma concentration | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 | Tmax is the time for maximum plasma concentration | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
| Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 | This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1. | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours) |
| Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 | This was determined by AUCtau/tau. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Apparent Clearance (CL/F) on Day 10 | Apparent oral clearance. This was determined by Dose/AUCtau. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10 | Apparent oral volume of distribution. This was determined by Dose/(AUCtau*kel) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
| Ritonavir Terminal Elimination Half-life (t½) on Day 10 | Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours) |
| Ritonavir Trough Concentration (Ctrough) on Day 5 | Concentration at pre-dose on Day 5. Observed directly from data. | Day 5 (pre-dose) |
| Ritonavir Trough Concentration (Ctrough) on Day 8 | Concentration at pre-dose on Day 8. Observed directly from data. | Day 8 (pre-dose) |
| Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose) | Concentration at pre-dose on Day 10. Observed directly from data. | Day 10 (pre-dose) |
| Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) | Concentration at 12 hour on Day 10. Observed directly from data. | Day 10 (12 hours after last dose) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10 | Cmax is maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
|
|
|
| Primary | PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 | Tmax is the time for maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Median | Full Range | hours (hr) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 | Tmax is the time for maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Median | Full Range | hours (hr) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
|
|
|
| Primary | PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 | Area under the plasma concentration-time profile from time Zero to time point on 12 hours | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
|
|
|
| Primary | PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 | This was determined by AUCtau/tau. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10 | Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
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| Primary | PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10 | Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
|
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| Primary | PF-07321332 Peak-to-trough Ratio (PTR) on Day 10 | This was determined by Day 10 Cmax/Day 10 Ctrough. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Apparent Clearance (CL/F) on Day 10 | Apparent oral clearance. This was determined by Dose/AUCtau. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10 | Apparent oral volume of distribution. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
|
|
|
| Primary | PF-07321332 Terminal Elimination Half-life (t½) on Day 10 | Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Mean | Standard Deviation | Hours (hr) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours) |
|
|
|
| Primary | PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast) | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours) |
|
|
|
| Primary | PF-07321332 Trough Concentration (Ctrough) on Day 5 | Concentration at pre-dose on Day 5. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 5 (pre-dose) |
|
|
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| Primary | PF-07321332 Trough Concentration (Ctrough) on Day 8 | Concentration at pre-dose on Day 8. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 8 (pre-dose) |
|
|
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| Primary | PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose) | Concentration at pre-dose on Day 10. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (pre-dose) |
|
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| Primary | PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) | Concentration at 12 hour time on Day 10. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (12 hours after last dose) |
|
|
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From baseline up to Day 42 |
|
|
|
| Secondary | Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria | Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease >= 30 mmHg, max. increase >=30 mmHg; diastolic BP min. <50mmHg; diastolic BP change from baseline max. decrease >=20, max. increase >=20; seated pulse rate min. <40 beats per minute (bpm) and max. >120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose) |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities | Safety laboratory assessments included hematology, urinalysis, and clinical chemistry. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day-1, Day 2, Day 5, Day 8, Day 10, Day 12. |
|
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| Secondary | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds[msec]) >450 and ≤480, or >480 and ≤500, or >500; Increase from baseline in QTcF (msec) >30 and ≤60, or>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline >200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose) |
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| Secondary | Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1 | Cmax is maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10 | Cmax is maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
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| Secondary | Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1 | Tmax is the time for maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Median | Full Range | hours (hr) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
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| Secondary | Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10 | Tmax is the time for maximum plasma concentration | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Median | Full Range | hours (hr) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours) |
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| Secondary | Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1 | This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10 | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast) | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours) |
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| Secondary | Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10 | This was determined by AUCtau/tau. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Apparent Clearance (CL/F) on Day 10 | Apparent oral clearance. This was determined by Dose/AUCtau. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10 | Apparent oral volume of distribution. This was determined by Dose/(AUCtau*kel) | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours) |
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| Secondary | Ritonavir Terminal Elimination Half-life (t½) on Day 10 | Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Mean | Standard Deviation | Hours (hr) | Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours) |
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| Secondary | Ritonavir Trough Concentration (Ctrough) on Day 5 | Concentration at pre-dose on Day 5. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 5 (pre-dose) |
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| Secondary | Ritonavir Trough Concentration (Ctrough) on Day 8 | Concentration at pre-dose on Day 8. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 8 (pre-dose) |
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| Secondary | Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose) | Concentration at pre-dose on Day 10. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (pre-dose) |
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| Secondary | Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose) | Concentration at 12 hour on Day 10. Observed directly from data. | The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 10 (12 hours after last dose) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 6 |
| 14 |
| Blood creatinine increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Urine Hemoglobin ≥ 1 |
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