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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004280-42 | EudraCT Number |
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This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. |
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| Cohort 2 | Experimental | Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. |
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| Cohort 3 | Experimental | Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07258669 | Drug | PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. | From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks) |
| Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality) | Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
| Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, standing systolic BP increase and decrease from BL of >=30mmHg, supine diastolic BP increase and decrease from BL of >=20mmHg, supine systolic BP increase and decrease from BL of >=30mmHg. | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
| Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of PF-07258669 | Cmax is the maximum observed plasma concentration. | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
| Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC-Main Office | South Miami | Florida | 33143 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants in Cohort 1 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo at 0.1mg, 0.3mg, 1mg, and 3mg on Day 1 in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo. |
| FG001 | Cohort 2 | Participants in Cohort 2 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo on Day 1 at 10mg, 30mg, 100mg, and 200mg in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo. |
| FG002 | Cohort 3 | Participants in Cohort 3 underwent 1 treatment period and received 300 mg PF-07258669 or placebo in a 3:1 manner on Day 1 in Period 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized participants who received a dose of study intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants in Cohort 1 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo at 0.1mg, 0.3mg, 1mg, and 3mg on Day 1 in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. | The safety analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks) |
From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pooled Placebo | All participants who received placebo in any period of any cohort |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac 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 | Nov 9, 2020 | Aug 3, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2021 | Aug 3, 2022 | SAP_001.pdf |
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| Placebo | Drug | Matching placebo will be prepared as an oral solution and/or suspension given in each cohort |
|
ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, QRS interval percent change from BL >=50%, QTcF change from BL >=30 and <=60msec, or change from BL >60msec. |
| From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
| Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings | The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee). | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
| At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
| Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669 | AUCinf is the area under the plasma concentration time profile from time 0 extrapolated to infinite time. | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
| Time for Cmax (Tmax) of PF-07258669 | Tmax is the time for Cmax. | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
| Terminal Half-life (t1/2) of PF-07258669 | t1/2 is the terminal half-life. | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
| Lost to Follow-up |
|
| BG001 | Cohort 2 | Participants in Cohort 2 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo on Day 1 at 10mg, 30mg, 100mg, and 200mg in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo. |
| BG002 | Cohort 3 | Participants in Cohort 3 underwent 1 treatment period and received 300 mg PF-07258669 or placebo in a 3:1 manner on Day 1 in Period 1. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Pooled Placebo | All participants who received placebo in any period of any cohort |
| OG001 | PF-07258669 0.1mg | Participants in Cohort 1 who received PF-07258669 0.1mg |
| OG002 | PF-07258669 0.3mg | Participants in Cohort 1 who received PF-07258669 0.3mg |
| OG003 | PF-07258669 1mg | Participants in Cohort 1 who received PF-07258669 1mg |
| OG004 | PF-07258669 3mg | Participants in Cohort 1 who received PF-07258669 3mg |
| OG005 | PF-07258669 10mg | Participants in Cohort 2 who received PF-07258669 10mg |
| OG006 | PF-07258669 30mg | Participants in Cohort 2 who received PF-07258669 30mg |
| OG007 | PF-07258669 100mg | Participants in Cohort 2 who received PF-07258669 100mg |
| OG008 | PF-07258669 200mg | Participants in Cohort 2 who received PF-07258669 200mg |
| OG009 | PF-07258669 300mg | Participants in Cohort 3 who received PF-07258669 300mg |
|
|
| Primary | Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality) | Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. | The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable laboratory values were analyzed. | Posted | Count of Participants | Participants | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
|
|
|
| Primary | Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, standing systolic BP increase and decrease from BL of >=30mmHg, supine diastolic BP increase and decrease from BL of >=20mmHg, supine systolic BP increase and decrease from BL of >=30mmHg. | The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable vital signs data were analyzed. | Posted | Count of Participants | Participants | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
|
|
|
| Primary | Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria | ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, QRS interval percent change from BL >=50%, QTcF change from BL >=30 and <=60msec, or change from BL >60msec. | The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable ECG data were analyzed. | Posted | Count of Participants | Participants | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
|
|
|
| Primary | Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings | The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee). | The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. | Posted | Count of Participants | Participants | From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks) |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) of PF-07258669 | Cmax is the maximum observed plasma concentration. | The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669 | AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. | The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669 | AUCinf is the area under the plasma concentration time profile from time 0 extrapolated to infinite time. | The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
|
|
|
| Secondary | Time for Cmax (Tmax) of PF-07258669 | Tmax is the time for Cmax. | The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated. | Posted | Median | Full Range | hour | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
|
|
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| Secondary | Terminal Half-life (t1/2) of PF-07258669 | t1/2 is the terminal half-life. | The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated. | Posted | Mean | Standard Deviation | hour | At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | PF-07258669 0.1mg | Participants in Cohort 1 who received PF-07258669 0.1mg | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | PF-07258669 0.3mg | Participants in Cohort 1 who received PF-07258669 0.3mg | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | PF-07258669 1mg | Participants in Cohort 1 who received PF-07258669 1mg | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | PF-07258669 3mg | Participants in Cohort 1 who received PF-07258669 3mg | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | PF-07258669 10mg | Participants in Cohort 2 who received PF-07258669 10mg | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | PF-07258669 30mg | Participants in Cohort 2 who received PF-07258669 30mg | 0 | 5 | 0 | 5 | 2 | 5 |
| EG007 | PF-07258669 100mg | Participants in Cohort 2 who received PF-07258669 100mg | 0 | 6 | 0 | 6 | 3 | 6 |
| EG008 | PF-07258669 200mg | Participants in Cohort 2 who received PF-07258669 200mg | 0 | 6 | 0 | 6 | 1 | 6 |
| EG009 | PF-07258669 300mg | Participants in Cohort 3 who received PF-07258669 300mg | 0 | 6 | 0 | 6 | 2 | 6 |
| Palpitations | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Noninfective gingivitis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
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| Vaccination complication | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA v24.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular 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 study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Standing diastolic BP decrease >=20mmHg |
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| Standing systolic BP increase >=30mmHg |
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| Standing systolic BP decrease >=30mmHg |
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| Supine diastolic BP increase >=20mmHg |
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| Supine diastolic BP decrease >=20mmHg |
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| Supine systolic BP increase >=30mmHg |
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| Supine systolic BP decrease >=30mmHg |
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| QRS interval %change >=50% |
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| QTcF change >=30 and <=60msec |
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| QTcF change >60msec |
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