Trial Outcomes & Findings for Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants (NCT NCT04863417)
NCT ID: NCT04863417
Last Updated: 2024-01-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
Results posted on
2024-01-25
Participant Flow
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.
Participant milestones
| Measure |
Cohort 1: PF-07038124 2000 Centimeter Square (cm^2) Body Surface Area (BSA)
Participants were randomized to receive PF-07038124 ointment 0.01 percentage (%) for topical application on 2000 cm\^2 of skin from Day 1 to Day 10 once daily (QD). The application area was identified by the investigator. Participants were followed up for 28 to 31 days after last dose of study drug.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
26-35 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Age, Customized
36-45 years
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Age, Customized
46-55 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Pooled Vehicle
n=4 Participants
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 11Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
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.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Pooled Vehicle
n=4 Participants
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 11Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
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.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Pooled Vehicle
n=4 Participants
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) During the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 11Population: Safety population included all randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the product they received.
Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Pooled Vehicle
n=4 Participants
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 Participants
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 Participants
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 Participants
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.
|
Pooled Vehicle
n=4 Participants
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
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
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 24 hours post dose on Day 1 and Day 10Population: 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).
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.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=4 Participants
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.
|
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.
|
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.
|
Pooled Vehicle
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124
Day 1
|
0.000 Picograms*hour per milliliter
Interval 0.0 to 0.0
|
0.000 Picograms*hour per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07038124
Day 10
|
0.000 Picograms*hour per milliliter
Interval 0.0 to 0.0
|
0.1650 Picograms*hour per milliliter
Interval 0.0 to 287.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 10: Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12, 24 hours post-dosePopulation: 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.
Cmax only for PF-07038124 reporting groups is reported.
Outcome measures
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 Participants
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=4 Participants
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.
|
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.
|
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.
|
Pooled Vehicle
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07038124
Day 1
|
0.000 Picograms per milliliter
Interval 0.0 to 0.0
|
0.000 Picograms per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07038124
Day 10
|
0.001965 Picograms per milliliter
Interval 0.0 to 14.9
|
0.03911 Picograms per milliliter
Interval 0.0 to 17.6
|
—
|
—
|
—
|
Adverse Events
Cohort 1: PF-07038124 2000 cm^2 BSA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: Vehicle 2000 cm^2 BSA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: PF-07038124 4000 cm^2 BSA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Vehicle 4000 cm^2 BSA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pooled Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: PF-07038124 2000 cm^2 BSA
n=4 participants at risk
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.
|
Cohort 1: Vehicle 2000 cm^2 BSA
n=2 participants at risk
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.
|
Cohort 2: PF-07038124 4000 cm^2 BSA
n=4 participants at risk
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.
|
Cohort 2: Vehicle 4000 cm^2 BSA
n=2 participants at risk
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.
|
Pooled Vehicle
n=4 participants at risk
This arm included participants who receive vehicle ointment for topical application on 2000 cm\^2 and 4000 cm\^2 of skin from Day 1 to Day 10 QD. The application area was identified by the investigator. Participants were followed up to 28 days after last dose of study drug.
|
|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
|
0.00%
0/2 • Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
|
25.0%
1/4 • Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
|
0.00%
0/2 • Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
|
0.00%
0/4 • Day 1 up to maximum of 31 days after last dose of study drug (maximum up to 41 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER