The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
PF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area
PF-07038124 0.01% or vehicle Ointment QD applied to 4000 cm2 Body Surface Area
P-one clinic, Keikokai medical corporation
Hachiōji, Tokyo, Japan
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)
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
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
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
Number of Participants Categorized According to Draize Scores (Maximum Score) for Local Skin Irritation Assessment During the Study, Regardless of Visit and Assessment Location
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
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
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