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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001020-15 | EudraCT Number |
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The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women. The study medicine consists of two medicines, nirmatrelvir and ritonavir. We are seeking female participants who are:
Participants will take the study medicine by mouth for a total of 3 times over 2 days (2 morning doses and 1 evening dose) at the study clinic. We will periodically collect breast milk from day 2 to 4 to measure the level of nirmatrelvir and ritonavir in it. A safety follow up call will be conducted around 28-35 days from the last dose to monitor any reactions participants may have to the study medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nirmatrelvir/ritonavir | Experimental | nirmatrelvir/ritonavir will be given by mouth two times a day as a tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nirmatrelvir | Drug | nirmatrelvir/ritonavir |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Time to Reach Cmax of Nirmatrelvir in Breast Milk | Cmax was defined as maximum observed concentration of nirmatrelvir in breast milk. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk | Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Terminal Half-Life of Nirmatrelvir in Breast Milk | The time measured for the breast milk nirmatrelvir concentration to decrease by one half. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Average Steady State Concentration of Nirmatrelvir in Breast Milk | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
Healthy lactating women
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| 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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Eleven participants were screened, of which 3 failed at screening. All the 8 participants who met the eligibility criteria were enrolled and assigned to the study treatment and treated with Nirmatrelvir 300 mg and Ritonavir 100 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nirmatrelvir 300 mg + Ritonavir 100 mg | Healthy lactating female who took nirmatrelvir 300 mg and ritonavir 100 mg for 3 doses (at 0, 12 hours post dose on Day 1, and 0 hours on Day 2, respectively) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nirmatrelvir 300 mg + Ritonavir 100 mg | Healthy lactating female who took nirmatrelvir 300 mg and ritonavir 100 mg for 3 doses (at 0, 12 hours post dose on Day 1, and 0 hours on Day 2, respectively) |
| 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 | The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms / milliliter (ng/mL) | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
|
From From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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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 | Nirmatrelvir 300 mg + Ritonavir 100 mg | Healthy lactating female who took nirmatrelvir 300 mg and ritonavir 100 mg for 3 doses (at 0, 12 hours post dose on Day 1, and 0 hours on Day 2, respectively) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | 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 | May 11, 2022 | Nov 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2022 | Nov 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C000718217 | nirmatrelvir |
| C000719967 | nirmatrelvir and ritonavir drug combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| ritonavir | Drug | nirmatrelvir/ritonavir |
|
|
| The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau | The amount of nirmatrelvir excreted into breast milk over the dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau | The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval . | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Breast Milk Clearance of Nirmatrelvir | Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Time to Reach Cmax of Ritonavir in Breast Milk |
Cmax was defined as maximum observed concentration of ritonavir in breast milk. |
| At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval | Area under the concentration curve for ritonavir in breast milk from time 0 to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Half-Life of Ritonavir in Breast Milk | The time measured for the breast milk ritonavir concentration to decrease by one half. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Average Steady State Concentration of Ritonavir in Breast Milk | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau | The amount of ritonavir excreted into breast milk over the dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau | The percent of ritonavir excreted in breast milk to amount of breast milk over the dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Breast Milk Clearance of Ritonavir | Clearance was defined as the apparent volume (L) of breast milk completely cleared the ritonavir per hour. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval | Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval | Area under the concentration curve for ritonavir in plasma from time 0 to end of dosing interval. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Half-Life of Nirmatrelvir in Plasma | The time measured for the plasma nirmatrelvir concentration to decrease by one half. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Half-Life of Ritonavir in Plasma | The time measured for the plasma ritonavir concentration to decrease by one half. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval | The minimum observed concentration and was directly observed from data. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval | The minimum observed concentration and was directly observed from data. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Time to Reach Cmax of Nirmatrelvir in Plasma | Cmax was defined as maximum observed concentration of nirmatrelvir in plasma. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Time to Reach Cmax of Ritonavir in Plasma | Cmax was defined as maximum observed concentration of ritonavir in plasma. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Apparent Clearance of Nirmatrelvir From Plasma | Clearance was defined as the apparent volume (L) of plasma completely cleared the nirmatrelvir per hour. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Apparent Clearance of Ritonavir From Plasma | Clearance was defined as the apparent volume (L) of plasma completely cleared the ritonavir per hour. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Apparent Volume of Nirmatrelvir Distribution | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Apparent Volume of Ritonavir Distribution | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| The Average Steady State Concentration of Nirmatrelvir in Plasma | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| The Average Steady State Concentration of Ritonavir in Plasma | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
| Daily (24 Hour) Amount of Nirmatrelvir Excreted in Breast Milk | Amount of nirmatrelvir excreted in breast milk in 24 hours. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Daily (24 Hour) Amount of Ritonavir Excreted in Breast Milk | Amount of ritonavir excreted in breast milk in 24 hours. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval | The ratio of area under the concentration-time profile for nirmatrelvir in milk to those in plasma from time zero to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval | The ratio of area under the concentration-time profile for ritonavir in milk to those in plasma from time zero to end of dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval | The ratio of the maximum concentration of nirmatrelvir in breast milk to those in plasma observed over the dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Milk to Plasma Ratio of Ritonavir for Cmax During Dosing Interval | The ratio of the maximum concentration of ritonavir in breast milk to those in plasma observed over the dosing interval. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Body Weight Normalized Infant Dose (BWNID) of Nirmatrelvir in mg/kg/Day | BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| BWNID of Ritonavir in mg/kg/Day | BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day | Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| BWNMD of Ritonavir in mg/kg/Day | Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Infant Dose Expressed As % of Body Weight Normalized Maternal Dose (BWNIDPCM) for Nirmatrelvir | BWNIDPCM = 100 * BWNID / BWNMD. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| BWNIDPCM for Ritonavir | BWNIDPCM = 100 * BWNID / BWNMD. | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
| Number of Participants With Treatment Emergent Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment. | From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days) |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | The laboratory abnormality parameters included urinalysis: urine bilirubin (>=1), urine hemoglobin (>=1) and leukocyte esterase (>=1). | At Screening (Day -28 to Day -2), Day -1, and Day 4 |
| Number of Participants With Vital Signs Abnormalities | Single supine blood pressure (BP), and pulse rate (PR) were performed following approximately a 5-minute rest in a supine position. BP, and PR assessments will be performed after collection of electrocardiogram (ECGs) and prior to collection of blood draws if scheduled at the same time. Vital signs abnormality included supine systolic BP <90mmHg. | At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2 |
| Number of Participants With ECG Abnormalities | Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements. | At Screening (from Day -28 to Day -2) |
| Number of Participants With Physical Examination Abnormalities | Physical examination included height, weight and body mass index (BMI, BMI = weight [kg] / height [m^2]) obtained for eligibility criteria. Physical examination abnormalities: BMI <17.5 kg/m^2; and a total body weight <=50 kg (110 lb). | At Screening (from Day -28 to Day -2) or Day -1 |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Time to Reach Cmax of Nirmatrelvir in Breast Milk | Cmax was defined as maximum observed concentration of nirmatrelvir in breast milk. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Median | Full Range | Hour | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk | Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour / milliliter (ng*hr/mL) | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | Terminal Half-Life of Nirmatrelvir in Breast Milk | The time measured for the breast milk nirmatrelvir concentration to decrease by one half. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Mean | Standard Deviation | Hour | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | The Average Steady State Concentration of Nirmatrelvir in Breast Milk | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau | The amount of nirmatrelvir excreted into breast milk over the dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milligram (mg) | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau | The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval . | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Primary | Breast Milk Clearance of Nirmatrelvir | Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/hr) | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Time to Reach Cmax of Ritonavir in Breast Milk | Cmax was defined as maximum observed concentration of ritonavir in breast milk. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Median | Full Range | Hour | At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval | Area under the concentration curve for ritonavir in breast milk from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Half-Life of Ritonavir in Breast Milk | The time measured for the breast milk ritonavir concentration to decrease by one half. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Mean | Standard Deviation | Hour | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | The Average Steady State Concentration of Ritonavir in Breast Milk | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau | The amount of ritonavir excreted into breast milk over the dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau | The percent of ritonavir excreted in breast milk to amount of breast milk over the dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Breast Milk Clearance of Ritonavir | Clearance was defined as the apparent volume (L) of breast milk completely cleared the ritonavir per hour. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval | The maximum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval | Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval | Area under the concentration curve for ritonavir in plasma from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Half-Life of Nirmatrelvir in Plasma | The time measured for the plasma nirmatrelvir concentration to decrease by one half. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Mean | Standard Deviation | Hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Half-Life of Ritonavir in Plasma | The time measured for the plasma ritonavir concentration to decrease by one half. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Mean | Standard Deviation | Hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval | The minimum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval | The minimum observed concentration and was directly observed from data. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Time to Reach Cmax of Nirmatrelvir in Plasma | Cmax was defined as maximum observed concentration of nirmatrelvir in plasma. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Median | Full Range | Hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Time to Reach Cmax of Ritonavir in Plasma | Cmax was defined as maximum observed concentration of ritonavir in plasma. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Median | Full Range | Hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Apparent Clearance of Nirmatrelvir From Plasma | Clearance was defined as the apparent volume (L) of plasma completely cleared the nirmatrelvir per hour. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Apparent Clearance of Ritonavir From Plasma | Clearance was defined as the apparent volume (L) of plasma completely cleared the ritonavir per hour. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Apparent Volume of Nirmatrelvir Distribution | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Apparent Volume of Ritonavir Distribution | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | The Average Steady State Concentration of Nirmatrelvir in Plasma | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | The Average Steady State Concentration of Ritonavir in Plasma | The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2 |
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| Secondary | Daily (24 Hour) Amount of Nirmatrelvir Excreted in Breast Milk | Amount of nirmatrelvir excreted in breast milk in 24 hours. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Daily (24 Hour) Amount of Ritonavir Excreted in Breast Milk | Amount of ritonavir excreted in breast milk in 24 hours. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval | The ratio of area under the concentration-time profile for nirmatrelvir in milk to those in plasma from time zero to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval | The ratio of area under the concentration-time profile for ritonavir in milk to those in plasma from time zero to end of dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval | The ratio of the maximum concentration of nirmatrelvir in breast milk to those in plasma observed over the dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Milk to Plasma Ratio of Ritonavir for Cmax During Dosing Interval | The ratio of the maximum concentration of ritonavir in breast milk to those in plasma observed over the dosing interval. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Body Weight Normalized Infant Dose (BWNID) of Nirmatrelvir in mg/kg/Day | BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/kg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | BWNID of Ritonavir in mg/kg/Day | BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/kg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day | Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/kg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | BWNMD of Ritonavir in mg/kg/Day | Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/kg/day | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Infant Dose Expressed As % of Body Weight Normalized Maternal Dose (BWNIDPCM) for Nirmatrelvir | BWNIDPCM = 100 * BWNID / BWNMD. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | BWNIDPCM for Ritonavir | BWNIDPCM = 100 * BWNID / BWNMD. | The PK parameter analysis population was defined as all participants assigned to study intervention and who took at least 1 dose of nirmatrelvir/ritonavir and in whom at least 1 of the PK parameters of interest was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days) |
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| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | The laboratory abnormality parameters included urinalysis: urine bilirubin (>=1), urine hemoglobin (>=1) and leukocyte esterase (>=1). | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | At Screening (Day -28 to Day -2), Day -1, and Day 4 |
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| Secondary | Number of Participants With Vital Signs Abnormalities | Single supine blood pressure (BP), and pulse rate (PR) were performed following approximately a 5-minute rest in a supine position. BP, and PR assessments will be performed after collection of electrocardiogram (ECGs) and prior to collection of blood draws if scheduled at the same time. Vital signs abnormality included supine systolic BP <90mmHg. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2 |
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| Secondary | Number of Participants With ECG Abnormalities | Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | At Screening (from Day -28 to Day -2) |
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| Secondary | Number of Participants With Physical Examination Abnormalities | Physical examination included height, weight and body mass index (BMI, BMI = weight [kg] / height [m^2]) obtained for eligibility criteria. Physical examination abnormalities: BMI <17.5 kg/m^2; and a total body weight <=50 kg (110 lb). | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | At Screening (from Day -28 to Day -2) or Day -1 |
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 26.1 | Non-systematic Assessment |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA version 26.1 | 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.
| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|