Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.
Interventions
PF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the ICD. 2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 4. Participants must have 4 biologically Japanese grandparents who were born in Japan. 5. BMI of 17.5 to 25 kg/m2; and a total body weight \>50 kg (110 lb). 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
1. Participants who have any visible skin damage or skin condition (eg, sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction. 2. Participants who have a history of or have active forms of dermatitides/eczematous conditions (eg, contact dermatitis, seborrhhoeic, discoid, gravitational, asteatotic and dishydrotic eczema) or other inflammatory skin diseases(eg, psoriasis, viral infection, fungal infection, bacterial infection) that would interfere with evaluation of the test site reaction. 3. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 4. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, or syphilis at screening. Hepatitis B vaccination is allowed. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 6. Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1. 7. Have undergone significant trauma or major surgery within 4 weeks of screening. 8. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. 9. Previous administration with an investigational drug within 4 months (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). 10. A positive urine drug test at screening and/or Day -1. 11. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. 12. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval \>450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmia's or tachyarrhythmias). 13. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: * AST or ALT level ≥1.5 × ULN; * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN. 14. A positive COVID-19 test at screening. 15. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine). 16. Blood donation (excluding plasma donations) of approximately ≥400 mL within 3 months or ≥200 mL within a month prior to dosing. Additionally, approximately ≥400 mL within 4 months for female participants. 17. History of serious adverse reactions or hypersensitivity to any topical drug; or known allergy to any of the study intervention or any components in the study intervention or history of hypersensitivity; or allergic reactions to any of the study preparations. 18. Not willing to refrain from shaving (Note: shaving around face is permitted), the use of depilatories or other hair-removal activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the treatment areas for 48 hours prior to admission to the CRU and for the duration of the stay in the CRU. 19. History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is planned to flush intravenous catheters. 20. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol. 21. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs During the Study | Day 1 up to Day 11 | Vital signs that were assessed included supine systolic blood pressure, diastolic blood pressure and supine pulse rate. Clinical significance was determined based on investigator's discretion. |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Day 1 up to Day 11 | Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion. |
| Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Through Day 1 to Day 11 (prior to application from Day 1-10 and 24 hours post application on Day 10) | Draize score was used to measure the skin irritability based on erythema, edema, papules, and vesicles at the administration site. Draize score ranged from 0 to 4, where 0 indicated no reaction visible, 1 indicated trace reaction (barely perceptible pinkness), 2 indicated mild reaction (readily visible pinkness), 3 indicated moderate reaction (definite redness) and 4 indicated strong to severe reaction (very intense redness). In this outcome measure number of participants are reported according to their maximum score they had during the study through Day 1 to 11, regardless of visit and assessment location. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, not necessarily considered related to the study intervention. SAEs were defined as any AE which occurred at any dose and resulted in any of following outcomes: death, life-threatening experience (risk of death at the time of event), required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly. TEAEs are events between first dose of study drug up to maximum of 31 days after last dose of study drug. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | Day 1 up to Day 11 | ECG parameters that were assessed included PR interval, QRS interval, QT interval, QTCF (Fridericia's correction formula) and heart rate. Clinical significance was determined based on investigator's discretion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07038124 | Day 1 and 10: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12, 24 hours post-dose | Cmax only for PF-07038124 reporting groups is reported. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124 | 0 to 24 hours post dose on Day 1 and Day 10 | AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose). AUCtau only for PF-07038124 reporting groups is reported. Participants must have a minimum of 3 quantifiable concentrations to report AUC. All concentrations lesser than lower limit of quantification, then AUCtau=0. |
Countries
Japan
Participant flow
Pre-assignment details
12 participants signed the informed consent form (ICF). All were enrolled into the study and randomized to a study treatment. None of them were screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA Participants were randomized to receive PF-07038124 ointment 0.01% for topical application on 2000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up for 28 to 31 days after last dose of study drug. | 4 |
| Cohort 1: Vehicle 2000 cm^2 BSA Participants were randomized to receive vehicle ointment for topical application on 2000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up for 28 to 31 days after last dose of study drug. | 2 |
| Cohort 2: PF-07038124 4000 cm^2 BSA Participants were randomized to receive PF-07038124 ointment 0.01% for topical application on 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up for 28 to 31 days after last dose of study drug. | 4 |
| Cohort 2: Vehicle 4000 cm^2 BSA Participants were randomized to receive vehicle ointment for topical application on 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up for 28 to 31 days after last dose of study drug. | 2 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cohort 1: PF-07038124 2000 cm^2 BSA | Cohort 1: Vehicle 2000 cm^2 BSA | Cohort 2: PF-07038124 4000 cm^2 BSA | Cohort 2: Vehicle 4000 cm^2 BSA | Total |
|---|---|---|---|---|---|
| Age, Customized 26-35 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Customized 36-45 years | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Customized 46-55 years | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 2 | 1 / 4 | 0 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 | 0 / 4 | 0 / 2 | 0 / 4 |
Outcome results
Primary
Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location
Draize score was used to measure the skin irritability based on erythema, edema, papules, and vesicles at the administration site. Draize score ranged from 0 to 4, where 0 indicated no reaction visible, 1 indicated trace reaction (barely perceptible pinkness), 2 indicated mild reaction (readily visible pinkness), 3 indicated moderate reaction (definite redness) and 4 indicated strong to severe reaction (very intense redness). In this outcome measure number of participants are reported according to their maximum score they had during the study through Day 1 to 11, regardless of visit and assessment location.
Time frame: Through Day 1 to Day 11 (prior to application from Day 1-10 and 24 hours post application on Day 10)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 4 | 0 Participants |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 0 | 4 Participants |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 1 | 0 Participants |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 2 | 0 Participants |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 3 | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 3 | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 0 | 2 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 4 | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 2 | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 1 | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 2 | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 3 | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 1 | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 0 | 4 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 4 | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 2 | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 1 | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 4 | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 0 | 2 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 3 | 0 Participants |
| Pooled Vehicle | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 0 | 4 Participants |
| Pooled Vehicle | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 2 | 0 Participants |
| Pooled Vehicle | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 3 | 0 Participants |
| Pooled Vehicle | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 1 | 0 Participants |
| Pooled Vehicle | Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location | Score 4 | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study
ECG parameters that were assessed included PR interval, QRS interval, QT interval, QTCF (Fridericia's correction formula) and heart rate. Clinical significance was determined based on investigator's discretion.
Time frame: Day 1 up to Day 11
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | 0 Participants |
| Pooled Vehicle | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Vital Signs During the Study
Vital signs that were assessed included supine systolic blood pressure, diastolic blood pressure and supine pulse rate. Clinical significance was determined based on investigator's discretion.
Time frame: Day 1 up to Day 11
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Vital Signs During the Study | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Vital Signs During the Study | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Vital Signs During the Study | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants With Clinically Significant Changes in Vital Signs During the Study | 0 Participants |
| Pooled Vehicle | Number of Participants With Clinically Significant Changes in Vital Signs During the Study | 0 Participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities
Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion.
Time frame: Day 1 up to Day 11
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants With Clinically Significant Laboratory Abnormalities | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants With Clinically Significant Laboratory Abnormalities | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants With Clinically Significant Laboratory Abnormalities | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants With Clinically Significant Laboratory Abnormalities | 0 Participants |
| Pooled Vehicle | Number of Participants With Clinically Significant Laboratory Abnormalities | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, not necessarily considered related to the study intervention. SAEs were defined as any AE which occurred at any dose and resulted in any of following outcomes: death, life-threatening experience (risk of death at the time of event), required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly. TEAEs are events between first dose of study drug up to maximum of 31 days after last dose of study drug.
Time frame: Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 0 Participants |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 0 Participants |
| Cohort 1: Vehicle 2000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 1 Participants |
| Cohort 2: PF-07038124 4000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Cohort 2: Vehicle 4000 cm^2 BSA | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 0 Participants |
| Pooled Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 0 Participants |
| Pooled Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124
AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose). AUCtau only for PF-07038124 reporting groups is reported. Participants must have a minimum of 3 quantifiable concentrations to report AUC. All concentrations lesser than lower limit of quantification, then AUCtau=0.
Time frame: 0 to 24 hours post dose on Day 1 and Day 10
Population: Pharmacokinetic (PK) analysis set included all participants who received at least one dose of PF-07038124 and in whom at least 1 plasma sample concentration value was reported. Here, 'Number Analyzed' signifies participants who had minimum of 3 concentrations to report AUCtau or when all concentrations LLOQ (AUCtau would be 0).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124 | Day 1 | 0.000 Picograms*hour per milliliter |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124 | Day 10 | 0.000 Picograms*hour per milliliter |
| Cohort 1: Vehicle 2000 cm^2 BSA | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124 | Day 1 | 0.000 Picograms*hour per milliliter |
| Cohort 1: Vehicle 2000 cm^2 BSA | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124 | Day 10 | 0.1650 Picograms*hour per milliliter |
Secondary
Maximum Observed Plasma Concentration (Cmax) of PF-07038124
Cmax only for PF-07038124 reporting groups is reported.
Time frame: Day 1 and 10: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12, 24 hours post-dose
Population: PK analysis set included all participants who received at least one dose of PF-07038124 and in whom at least 1 plasma sample concentration value was reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: PF-07038124 2000 cm^2 BSA | Maximum Observed Plasma Concentration (Cmax) of PF-07038124 | Day 1 | 0.000 Picograms per milliliter |
| Cohort 1: PF-07038124 2000 cm^2 BSA | Maximum Observed Plasma Concentration (Cmax) of PF-07038124 | Day 10 | 0.001965 Picograms per milliliter |
| Cohort 1: Vehicle 2000 cm^2 BSA | Maximum Observed Plasma Concentration (Cmax) of PF-07038124 | Day 1 | 0.000 Picograms per milliliter |
| Cohort 1: Vehicle 2000 cm^2 BSA | Maximum Observed Plasma Concentration (Cmax) of PF-07038124 | Day 10 | 0.03911 Picograms per milliliter |