| Primary | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | | OG002 | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. | | OG003 | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. |
| | | Title | Denominators | Categories |
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| All-causality TEAEs | | |
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| Primary | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 to 41 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Primary | Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD | An AE was 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. An AE was considered a TEAE if the event started during the effective duration of treatment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 up to 37 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | | OG002 | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. |
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| Primary | Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD | An adverse event (AE) was 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. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 to 41 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG002 | Part 2: Placebo 120-hours Continuous Infusion | |
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| Primary | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters. | Posted | | Count of Participants | | Participants | | Day 1 up to 6 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Primary | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters. | Posted | | Count of Participants | | Participants | | Day 1 up to 41 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
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| Primary | Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (pre-dose Day 1), Day 1-30 minutes, 2 hours, 6 hour, and 12 hours; 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2). | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD | Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (pre-dose Day 1), Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET) . | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | |
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| Primary | Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | bpm | | Baseline (pre-dose Day 1), 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day 1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2). | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | | OG002 |
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| Primary | Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD | Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | bpm | | Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET). | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2). | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | | OG002 |
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| Primary | Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD | Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET). | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2). | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. | |
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| Primary | Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD | Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET). | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 1. Participants will be analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | percentage of SpO2 | | Baseline (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD | Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 2. Participants will be analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | percentage of SpO2 | | Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination (ET). | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
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| Primary | Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Millisecond | | Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Primary | Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD | The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point. | Posted | | Mean | Standard Deviation | Millisecond | | Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET) | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Secondary | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD | C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 1: SAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination. | | | | ID | Title | Description |
|---|
| OG000 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion. | | OG001 | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion. |
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| Secondary | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD | C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | | | | ID | Title | Description |
|---|
| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Secondary | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD | Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | | | | ID | Title | Description |
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| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Secondary | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD | t½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters. | Posted | | Mean | Standard Deviation | hour | | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | | | | ID | Title | Description |
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| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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| Secondary | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD | Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | | | | ID | Title | Description |
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| OG000 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (~120 hours) continuous intravenous infusion. | | OG001 | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (~120 hours) continuous intravenous infusion. |
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