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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507074-40-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-07220060 by mouth |
|
| Cohort 2 | Experimental | Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral [14C]PF-07220060 | Drug | A single oral dose of [14C]PF-07220060, will be administered as a liquid formulation in Cohort 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Total Radiocarbon (14C) Excreted in Urine | Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060. | From Predose up to 14 days post-dose |
| Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1 | Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060. | From Predose up to 14 days post-dose |
| Cumulative Percent Recovery of Total Radiocarbon (14C) | Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose. | From Predose up to 14 days post-dose |
| Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1 | The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | From Predose up to 96 hours post-dose |
| Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2 | Dose normalized AUCinf (AUCinf[dn]) was calculated as AUCinf/Dose, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability was defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07220060 (i.e., unlabeled PF-07220060) to AUCinf(dn) following intravenously administered [14C]PF-07220060 and reported in the statistical analysis section. |
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Key Eligibility criteria for this study include, but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: 14C PF-07220060 100 mg Oral | Participants received a single oral dose of 100 milligram (mg) radiocarbon (14C)- labeled PF-07220060 containing approximately 300 nanocurie (nCi) 14C on Day 1. |
| FG001 | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Participants received a single oral dose of 100 mg unlabeled PF-07220060 followed by a single intravenous (IV) microtracer microdose of 100 micrograms (mcg) (14C) PF-07220060 containing approximately 300 nCi 14C on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis set comprised of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 14C PF-07220060 100 mg Oral | Participants received a single oral dose of 100 mg 14C- labeled PF-07220060 containing approximately 300 nCi 14C on Day 1. |
| BG001 | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV |
| 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 | Percentage of Total Radiocarbon (14C) Excreted in Urine | Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060. | Mass balance population analysis set: evaluable participants with 1 dose of 14C PF-07220060, who completed total radioactivity concentration (urinary and fecal) data, had no protocol deviations to affect the mass balance analysis. Participants who vomited 24 hours post oral dosing were included in analysis. Participants who vomited within 24 hours post oral dosing or had inconsistent mass balance data for any other reason were excluded from the analysis at discretion of the pharmacokineticist. | Posted | Mean | Standard Deviation | Percentage of 14C in urine | From Predose up to 14 days post-dose |
|
Baseline up to 35 days after the last dose of study intervention (up to Day 36)
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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 | Cohort 1: 14C PF-07220060 100 mg Oral | Participants received a single oral dose of 100 mg 14C- labeled PF-07220060 containing approximately 300 nCi 14C on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0MedDRA | 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 | Dec 6, 2023 | Apr 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2023 | Apr 2, 2025 | SAP_001.pdf |
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| Oral PF-07220060 | Drug | A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2. |
|
| IV [14C] PF-07220060 | Drug | A single IV infusion of [14C]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose. |
|
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. |
| From Predose up to 144 hours post-dose |
| Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1 | The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | From Predose up to 196 hours post-dose |
| Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2 | The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | From Predose up to 196 hours post-dose |
| From Predose up to 14 days post-dose |
| Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa) | Fraction of dose absorbed (Fa) was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time 0 to the time of last measurable concentration) following oral and IV administration of [14C]PF-07220060 microtracer doses in cohort 1 and 2, respectively. The total radioactivity excreted in urine following oral and IV administration, expressed as percentage of radioactive dose administered is reported in the descriptive section and fraction of dose absorbed is reported in the statistical analysis section. | From Predose up to 14 days post-dose |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. TEAEs were defined as any AEs that occurred following start of study intervention and during follow-up within the lag time of up to 35 days after the last dose of study intervention. | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Following laboratory parameters were analyzed: clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonates, total bilirubin, calcium, chloride, creatinine, cystatin C, estimated glomerular filtration rate (eGFR) serum creatinine, glucose, potassium, protein, sodium, uric acid, blood urea nitrogen. Hematology included basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocyte count. Urinalysis included: glucose, blood, ketones, leukocytes esterase, nitrite, protein and pH. Clinical significance of laboratory abnormalities was determined by investigator. | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital signs included blood pressure and pulse rate. Blood pressure was measured with the participant in a supine position using an automated device after at least 5 minutes rest for the participant. Clinical significance of vital signs was determined based on investigator's discretion. | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QT and, corrected QT interval using Fridericia's formula (QTcF) and QRS interval. Clinical significance of ECG abnormalities was determined based on investigator's discretion. | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
Participants received a single oral dose of 100 mg unlabeled PF-07220060 followed by a single IV microtracer microdose of 100 mcg 14C PF-07220060 containing approximately 300 nCi 14C on Day 1.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received a single oral dose of 100 mg 14C- labeled PF-07220060 containing approximately 300 nCi 14C on Day 1.
| OG001 | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Participants received a single oral dose of 100 mg unlabeled PF-07220060 followed by a single IV microtracer microdose of 100 mcg 14C PF-07220060 containing approximately 300 nCi 14C on Day 1. |
|
|
| Primary | Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1 | Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)*100 where, 14C dose was administered dose of 14C PF-07220060. | Mass balance population analysis set. Participants who vomited 24 hours post oral dosing were included in analysis. Participants who vomited within 24 hours post oral dosing or had inconsistent mass balance data for any other reason were excluded from the analysis at discretion of the pharmacokineticist. This outcome measure was not planned to be analyzed in Cohort 2 as pre-specified in Protocol. | Posted | Mean | Standard Deviation | Percentage of 14C in feces | From Predose up to 14 days post-dose |
|
|
|
| Primary | Cumulative Percent Recovery of Total Radiocarbon (14C) | Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose. | Mass balance population analysis set. Participants who vomited 24 hours post oral dosing were included in analysis. Participants who vomited within 24 hours post oral dosing or had inconsistent mass balance data for any other reason were excluded from the analysis at discretion of the pharmacokineticist. | Posted | Mean | Standard Deviation | Percentage of 14C in urine and feces | From Predose up to 14 days post-dose |
|
|
|
| Primary | Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1 | The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | The PK concentration population for PF-07220060 was defined as all participants dosed with PF-07220060 who had at least one PF-07220060 concentration. This outcome measure was not planned to be analyzed in Cohort 2 as pre-specified in Protocol. | Posted | Number | Metabolite percentage of total plasma RA | From Predose up to 96 hours post-dose |
|
|
|
| Primary | Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1 | The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | The PK concentration population for PF-07220060 was defined as all participants dosed with PF-07220060 who had at least one PF-07220060 concentration. This outcome measure was not planned to be analyzed in Cohort 2 as pre-specified in Protocol. | Posted | Number | Recovered metabolite as % of RA given | From Predose up to 144 hours post-dose |
|
|
|
| Primary | Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1 | The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | The PK concentration population for PF-07220060 was defined as all participants dosed with PF-07220060 who had at least one PF-07220060 concentration. This outcome measure was not planned to be analyzed in Cohort 2 as pre-specified in Protocol. | Posted | Number | Recovered metabolite as % of RA given | From Predose up to 196 hours post-dose |
|
|
|
| Primary | Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2 | The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples. | The PK concentration population for PF-07220060 was defined as all participants dosed with PF-07220060 who had at least one PF-07220060 concentration. This outcome measure was not planned to be analyzed in Cohort 1 as pre-specified in Protocol. | Posted | Number | Recovered metabolite as % of RA given | From Predose up to 196 hours post-dose |
|
|
|
| Secondary | Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2 | Dose normalized AUCinf (AUCinf[dn]) was calculated as AUCinf/Dose, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability was defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07220060 (i.e., unlabeled PF-07220060) to AUCinf(dn) following intravenously administered [14C]PF-07220060 and reported in the statistical analysis section. | The PK parameter population analysis set for PF-07220060 was defined as all participants dosed with PF-07220060, who have at least one estimated PF-07220060 PK parameter of interest. The outcome measure was not planned to be analyzed for Cohort 1 as pre-specified in the protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/ milliliter/ milligram | From Predose up to 14 days post-dose |
|
|
|
|
| Secondary | Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa) | Fraction of dose absorbed (Fa) was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time 0 to the time of last measurable concentration) following oral and IV administration of [14C]PF-07220060 microtracer doses in cohort 1 and 2, respectively. The total radioactivity excreted in urine following oral and IV administration, expressed as percentage of radioactive dose administered is reported in the descriptive section and fraction of dose absorbed is reported in the statistical analysis section. | The PK parameter population analysis set for PF-07220060 was defined as all participants dosed with PF-07220060, who have at least one estimated PF-07220060 PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of radioactive dose | From Predose up to 14 days post-dose |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. TEAEs were defined as any AEs that occurred following start of study intervention and during follow-up within the lag time of up to 35 days after the last dose of study intervention. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Following laboratory parameters were analyzed: clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonates, total bilirubin, calcium, chloride, creatinine, cystatin C, estimated glomerular filtration rate (eGFR) serum creatinine, glucose, potassium, protein, sodium, uric acid, blood urea nitrogen. Hematology included basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocyte count. Urinalysis included: glucose, blood, ketones, leukocytes esterase, nitrite, protein and pH. Clinical significance of laboratory abnormalities was determined by investigator. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital signs included blood pressure and pulse rate. Blood pressure was measured with the participant in a supine position using an automated device after at least 5 minutes rest for the participant. Clinical significance of vital signs was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QT and, corrected QT interval using Fridericia's formula (QTcF) and QRS interval. Clinical significance of ECG abnormalities was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to 35 days after the last dose of study intervention (up to Day 36) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Cohort 2: PF-07220060 100 mg Oral + 14C PF-07220060 100 mcg IV | Participants received a single oral dose of 100 mg unlabeled PF-07220060 followed by a single IV microtracer microdose of 100 mcg 14C PF-07220060 containing approximately 300 nCi 14C on Day 1. | 0 | 6 | 0 | 6 | 4 | 6 |
| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v27.0MedDRA | Non-systematic Assessment |
|
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.
| Title | Measurements |
|---|
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| M3 |
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| 496b |
|
| Title | Measurements |
|---|
|
| M3 |
|
| 496b |
|
| Title | Measurements |
|---|
|
| M3 |
|
| 496b |
|
| Title | Measurements |
|---|
|
| M3 |
|
| 496b |
|