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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002121-28 | EudraCT Number |
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The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2) |
|
| Part 2 | Experimental | Repeated, Escalating Doses of PF-07202954 or placebo from Day 1 to Day 14, inclusive (Cohorts 3, 4, 5, 6 7, and optional Cohort 8) |
|
| Part 3 | Experimental | Single dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07202954 Repeat Dose | Drug | 10, 30, 100, 300, 600, 1200 milligrams (mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1 | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose. | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
| Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (less than [<] 0.8* lower limit normal [LLN]); monocytes/leukocytes (greater than [>] 1.2* upper limit normal [ULN]); clinical chemistry: low density lipoprotein (LDL) (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (greater than equal to [>=1]), urine erythrocytes (>= 20), red blood cells (RBC) casts (>1), bacteria (>20). Number of participants with any laboratory abnormality meeting pre-defined criteria was reported in this outcome measure. | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
| Number of Participants According to Categorization of Vital Signs Data: Part 1 | Vital signs were categorized according to the following criteria for potential clinical concern: diastolic blood pressure (DBP): <50 millimeter of mercury (mmHg), increase from baseline >= 20mmHg; systolic blood pressure (SBP): <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 beats per minute (bpm), >120 bpm. | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
| Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 | ECG parameters were categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50 percent (%); QRS duration, aggregate (msec) >=140, percent change >= 50%; QT interval corrected by Fridericia's formula (QTcF) interval aggregate (msec): >450 to <=480, > 480 to <=500, >500, change from baseline: >30 to <=60 and change >60. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1 | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) | |
| Time for Cmax (Tmax) of PF-07202954: Part 1 | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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Inclusion Criteria:- healthy subjects (all 3 Parts)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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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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Study originally had 3 parts. Sponsor strategically decided not to conduct Part 2 and 3, based on results from Part 1 of the study. This decision was not due to any safety concern from Part 1 of the study. The study was concluded following Part 1; hence, no participants were enrolled in Part 2 and 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part1 Cohort1: Placebo/PF-07202954 100mg Std Meal/PF-07202954 600mg/PF-07202954 100mg High Fat Meal | Participants were administered a single oral dose of placebo with a standard (std) meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG001 | Part1 Cohort1: PF-07202954 10mg/Placebo/PF-07202954 600mg/PF-07202954 100mg High Fat Meal | Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of placebo with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG002 | Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/Placebo/PF-07202954 100mg High Fat Meal | Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of placebo with a std meal and PF-07202954 100 mg with high fat/high calorie meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG003 | Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/PF-07202954 600mg/Placebo | Participants were administered a single oral dose of PF-07202954 10 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 100 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 600 mg and placebo with std meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG004 | Part1 Cohort2: Placebo/PF-07202954 300mg/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted | Participants were administered a single oral dose of placebo with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG005 | Part1 Cohort2: PF-07202954 30mg/Placebo/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted | Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of placebo with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG006 | Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/Placebo/PF-07202954 100mg Fasted | Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of placebo with a std meal and PF-07202954 100 mg under fasting condition on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| FG007 | Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/PF-07202954 100mg Std Meal/Placebo | Participants were administered a single oral dose of PF-07202954 30 mg with a std meal on Day 1 of Period 1 followed by a single oral dose of PF-07202954 300 mg with a std meal on Day 1 of Period 2. Participants received a single oral dose of PF-07202954 100 mg and placebo with a std meal on Day 1 of Periods 3 and 4, respectively. The dosing in each period was separated by an interval of at least 10 days. Participants were followed up for approximately 28 days after last dose of study treatment in Period 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Period 1 |
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| Part 1 Period 2 |
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| Part 1 Period 3 |
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| Part 1 Period 4 |
|
Data has been presented for all participants in Cohort 1 and 2 as presenting the data per sequence would risk re-identification of participants due to low enrollment of participants per sequence. The study was concluded following Part 1; hence, no participants were enrolled in Part 2 and 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Cohort 1: All Participants | All participants who were randomized to either of the four treatment sequences in Cohort 1 and received placebo and escalating doses of PF-07202954 either with std meal or with high fat/high calorie meal in Periods 1, 2, 3 or 4 were included. All doses were administered once on Day 1 of each period via the oral route. The dosing in each period was separated by an interval of at least 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1 | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose. | Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
|
From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) for Part 1
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1. Since there was no enrolment for Part 2 and 3, hence no safety data collected and reported.
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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 and 2: Placebo: Part 1 | Participants were administered a single oral dose of placebo with a standard meal on Day 1 of any treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2020 | Sep 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2021 | Aug 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
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| PF-07202954 Single Dose |
| Drug |
10, 30, 100, 300, 600, 900, 1200 milligrams (mg) |
|
| Placebo | Drug | Matching Placebo |
|
| From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
| Number of Participants With TEAEs: Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to a maximum of 12 weeks |
| Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20). | Up to a maximum of 12 weeks |
| Number of Participants According to Categorization of Vital Signs Data: Part 2 | Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm. | Up to a maximum of 12 weeks |
| Number of Participants According to Categorization of ECG Data: Part 2 | ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60. | Up to a maximum of 12 weeks |
| Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3 | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Time for Cmax (Tmax) of PF-07202954: Part 3 | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3 | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1 | AUClast was determined by linear/log trapezoidal method. | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1 | AUCinf was determined as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate constant. Treatment groups with same dose and administration were combined as planned. | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Terminal Half-life (t1/2) of PF-07202954: Part 1 | T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Treatment groups with same dose and administration were combined as planned. | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
| Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2 | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2 | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (AUCtau) of PF-07202954 on Day 1, 7 and 14: Part 2 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau). | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2 | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2 | Aetau was defined as amount of unchanged drug recovered in urine during dosing interval. | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2 | Aetau% was defined as percent of dose recovered in urine as unchanged drug over dosing interval. | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2 | Renal clearance was amount of unchanged drug excreted in urine over the dosing interval divided by AUCtau. | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
| Number of Participants With TEAEs: Part 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to maximum of 6 weeks |
| Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20). | Up to maximum of 6 weeks |
| Number of Participants According to Categorization of Vital Signs Data: Part 3 | Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm. | Up to maximum of 6 weeks |
| Number of Participants According to Categorization of ECG Data: Part 3 | ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60. | Up to maximum of 6 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Part 1 Cohort 2: All Participants | All participants who were randomized to either of the four treatment sequences in Cohort 2 and received placebo and escalating doses of PF-07202954 with either std meal or under fasting condition in Period 1, 2, 3 or 4 were included. All doses were administered once on Day 1 of each period via the oral route. The dosing in each period was separated by an interval of at least 10 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort 1: PF-07202954 10 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period. |
| OG002 | Cohort 2: PF-07202954 30 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period. |
| OG003 | Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period. |
| OG004 | Cohort 2: PF-07202954 300 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period. |
| OG005 | Cohort 1: PF-07202954 600 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period. |
| OG006 | Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period. |
| OG007 | Cohort 2: PF-07202954 100 mg Fasted: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period. |
|
|
| Primary | Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (less than [<] 0.8* lower limit normal [LLN]); monocytes/leukocytes (greater than [>] 1.2* upper limit normal [ULN]); clinical chemistry: low density lipoprotein (LDL) (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (greater than equal to [>=1]), urine erythrocytes (>= 20), red blood cells (RBC) casts (>1), bacteria (>20). Number of participants with any laboratory abnormality meeting pre-defined criteria was reported in this outcome measure. | Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
|
|
|
| Primary | Number of Participants According to Categorization of Vital Signs Data: Part 1 | Vital signs were categorized according to the following criteria for potential clinical concern: diastolic blood pressure (DBP): <50 millimeter of mercury (mmHg), increase from baseline >= 20mmHg; systolic blood pressure (SBP): <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 beats per minute (bpm), >120 bpm. | Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
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|
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| Primary | Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1 | ECG parameters were categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50 percent (%); QRS duration, aggregate (msec) >=140, percent change >= 50%; QT interval corrected by Fridericia's formula (QTcF) interval aggregate (msec): >450 to <=480, > 480 to <=500, >500, change from baseline: >30 to <=60 and change >60. | Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks) |
|
|
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| Primary | Number of Participants With TEAEs: Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Up to a maximum of 12 weeks |
|
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| Primary | Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20). | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Up to a maximum of 12 weeks |
|
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| Primary | Number of Participants According to Categorization of Vital Signs Data: Part 2 | Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Up to a maximum of 12 weeks |
|
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| Primary | Number of Participants According to Categorization of ECG Data: Part 2 | ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Up to a maximum of 12 weeks |
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3 | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
|
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| Primary | Time for Cmax (Tmax) of PF-07202954: Part 3 | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Primary | Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3 | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Primary | Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1 | Pharmacokinetic (PK) parameter population included all participants who received at least 1 dose of PF-07202954 and had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Treatment groups with same dose and administration were combined as planned. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Time for Cmax (Tmax) of PF-07202954: Part 1 | PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. Treatment groups with same dose and administration were combined as planned. | Posted | Median | Full Range | Hours | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1 | AUClast was determined by linear/log trapezoidal method. | PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in the statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Treatment groups with same dose and administration were combined as planned. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1 | AUCinf was determined as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate constant. Treatment groups with same dose and administration were combined as planned. | PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. PK data was not summarized for doses with less than 3 participants as pre-specified in the statistical analysis plan; hence, individual values were reported for 'Cohort 2: PF-07202954 100 mg Fasted: Part 1' arm. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Terminal Half-life (t1/2) of PF-07202954: Part 1 | T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Treatment groups with same dose and administration were combined as planned. | PK parameter population included all participants who received at least 1 dose of PF-07202954 and who had at least 1 of the PK parameters of interest calculated in Part 1. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hours | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2 | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2 | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (AUCtau) of PF-07202954 on Day 1, 7 and 14: Part 2 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau). | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2 | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2 | Aetau was defined as amount of unchanged drug recovered in urine during dosing interval. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2 | Aetau% was defined as percent of dose recovered in urine as unchanged drug over dosing interval. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2 | Renal clearance was amount of unchanged drug excreted in urine over the dosing interval divided by AUCtau. | Data was not collected as no participants were enrolled in Part 2 of the study. | Posted | Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours) |
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| Secondary | Number of Participants With TEAEs: Part 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Up to maximum of 6 weeks |
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| Secondary | Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3 | Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20). | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Up to maximum of 6 weeks |
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| Secondary | Number of Participants According to Categorization of Vital Signs Data: Part 3 | Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm. | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Up to maximum of 6 weeks |
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| Secondary | Number of Participants According to Categorization of ECG Data: Part 3 | ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60. | Data was not collected as no participants were enrolled in Part 3 of the study. | Posted | Up to maximum of 6 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Cohort 1: PF-07202954 10 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 10 mg with a standard meal on Day 1 of any treatment period. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Cohort 2: PF-07202954 30 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 30 mg with a standard meal on Day 1 of any treatment period. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg with a standard meal on Day 1 of any treatment period. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | Cohort 2: PF-07202954 300 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 300 mg with a standard meal on Day 1 of any treatment period. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | Cohort 1: PF-07202954 600 mg: Part 1 | Participants were administered a single oral dose of PF-07202954 600 mg with a standard meal on Day 1 of any treatment period. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG006 | Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg with a high fat/ high calorie meal on Day 1 of any treatment period. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG007 | Cohort 2: PF-07202954 100 mg Fasted: Part 1 | Participants were administered a single oral dose of PF-07202954 100 mg under fasting condition on Day 1 of any treatment period. | 0 | 2 | 0 | 2 | 0 | 2 |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Application site irritation | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Lymph node palpable | Investigations | MedDRA v24.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| DBP: Increase from baseline >=20mmHg |
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| SBP: <90 mmHg |
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| SBP: Increase from baseline >=30 mmHg |
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| Pulse rate: <40 bpm |
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| Pulse rate: >120 bpm |
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| PR interval aggregate (msec): percent change >=25/50% |
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| QRS duration, aggregate (msec): >=140 |
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| QRS duration, aggregate (msec): percent change >=50% |
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| QTcF interval aggregate (msec): >450 to <=480 |
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| QTcF interval aggregate (msec): >480 to <=500 |
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| QTcF interval aggregate (msec): >=500 |
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| QTcF interval aggregate (msec): >30 to <=60 |
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| QTcF interval aggregate (msec): change >60 |
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