Trial Outcomes & Findings for A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955 (NCT NCT05206604)
NCT ID: NCT05206604
Last Updated: 2024-11-14
Results Overview
An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-related AEs and SAEs were determined by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to the end of follow up (ie, up to 44 days)
Results posted on
2024-11-14
Participant Flow
Twenty-four participants were enrolled in the study, with 6 participants assigned to each of the 4 cohorts. All 24 participants were treated: 23 completed the study and 1 discontinued from the study due to non-compliance with study intervention.
Participant milestones
| Measure |
Cohort 1 PF-07295324 0.12% Ointment Twice Daily (BID)
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% body surface area (BSA) or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment Once Daily (QD)
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
4
|
2
|
4
|
2
|
4
|
2
|
|
Overall Study
Received Treatment
|
4
|
2
|
4
|
2
|
4
|
2
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
2
|
4
|
1
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 PF-07295324 0.12% Ointment Twice Daily (BID)
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% body surface area (BSA) or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment Once Daily (QD)
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955
Baseline characteristics by cohort
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 44 Years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Age, Customized
45 - 60 Years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to the end of follow up (ie, up to 44 days)Population: All participants randomly assigned to study intervention and who are applied at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-related AEs and SAEs were determined by the investigator.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with treatment-related AEs
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At screening, admission (Day -1), on Days 5, 7, 10, at discharge (Day 12), and at early termination if applicablePopulation: All participants randomly assigned to study intervention and who are applied at least 1 dose of study intervention.
Hematology parameters included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils, reticulocytes, and lymphocytes. Chemistry parameters included blood urea nitrogen, creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had abnormal data were reported.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Neutrophils <0.8*lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils/Leukocytes <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Eosinophils/Leukocytes >1.2*upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Monocytes/Leukocytes >1.2*ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Bicarbonate < 0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
URINE Bilirubin >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocyte Esterase >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At screening, on Days 1, 2, 5, 7, 10, 11, at discharge (Day 12), and at early termination if applicablePopulation: All participants randomly assigned to study intervention and who are applied at least 1 dose of study intervention.
Criteria for abnormality in vital signs: supine pulse rate \<40 beats per minute (bpm) or \>120 bpm; supine diastolic blood pressure (DBP) \<50 mmHg, maximum increase or decrease from baseline of \>=20 mmHg; supine systolic blood pressure (SBP) \<90 mmHg, maximum increase or decrease from baseline of \>=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
Systolic blood pressure decrease >=30 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Diastolic blood pressure increase >=20 mmHg
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Diastolic blood pressure decrease >=20 mmHg
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At screening, on Days 1, 2, 5, 7, 10, 11, at discharge (Day 12), and at early termination if applicablePopulation: All participants randomly assigned to study intervention and who are applied at least 1 dose of study intervention.
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450\<= QTcF \<480, 480\<= QTcF \<500, and QTcF \>=500; QTcF maximum increase from baseline (msec): 30\<= change \<60, and change \>=60; 2) maximum PR interval (msec): \>=300; PR increase from baseline (msec): baseline \>200 with 25% increase at maximum, baseline \<=200 with 50% increase at maximum; 3) maximum QRS (msec): \>=140; QRS increase from baseline (msec) \>=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening up to Day 12 or early termination if applicablePopulation: All participants randomly assigned to study intervention and who are applied at least 1 dose of study intervention.
Application site toleration was assessed by Draize scoring. Draize scores were defined as: 0 = No reaction visible, 1 = Trace reaction - barely perceptible pinkness, 2 = Mild reaction - readily visible pinkness, 3 = Moderate reaction - definite redness, 4 = Strong to severe reaction - very intense redness. Participants with at least 1 instance of Draize score \>0 were listed.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 Participants
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 Participants
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Skin Irritation Assessments Using Draize Scoring
Draize Score = 0
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Skin Irritation Assessments Using Draize Scoring
Draize Score = 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Skin Irritation Assessments Using Draize Scoring
Draize Score = 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Skin Irritation Assessments Using Draize Scoring
Draize Score = 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Skin Irritation Assessments Using Draize Scoring
Draize Score = 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated.
Cmax was defined as maximum plasma concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07295324 on Days 1 and 10
Day 1
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07295324 on Days 1 and 10
Day 10
|
0.001655 ng/mL
Geometric Coefficient of Variation 19579
|
0.001502 ng/mL
Geometric Coefficient of Variation 13373
|
0.002006 ng/mL
Geometric Coefficient of Variation 40943
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated. In "overall number of participants analyzed", the total number of participants in each treatment group was presented, and in "number analyzed", the number of participants contributing to the data was presented.
Tmax was defined as time to reach maximum observed plasma concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=2 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07295324 on Days 1 and 10
Day 10
|
NA hour
Interval 4.0 to 6.0
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful median when sample size was less than 3.
|
NA hour
Interval 0.0 to 8.02
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful median when sample size was less than 3.
|
NA hour
Interval 4.0 to 8.0
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful median when sample size was less than 3.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated. In "overall number of participants analyzed", the total number of participants in each treatment group was presented, and in "number analyzed", the number of participants contributing to the data was presented.
AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of PF-07295324 on Days 1 and 10
Day 1
|
0.0001000 ng*hr/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng*hr/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng*hr/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of PF-07295324 on Days 1 and 10
Day 10
|
0.001262 ng*hr/mL
Geometric Coefficient of Variation 1539186
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful geometric mean and geometric coefficient of variation when sample size was less than 3.
|
0.002037 ng*hr/mL
Geometric Coefficient of Variation 82741202
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated. In "overall number of participants analyzed", the total number of participants in each treatment group was presented, and in "number analyzed", the number of participants contributing to the data was presented.
Cavg was defined as average plasma concentration. It was determined by AUCtau/tau; where tau was the dosing interval and AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=3 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=3 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration (Cavg) of PF-07295324 on Days 1 and 10
Day 10
|
0.0005518 ng/mL
Geometric Coefficient of Variation 7950
|
NA ng/mL
Geometric Coefficient of Variation NA
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful geometric mean and geometric coefficient of variation when sample size was less than 3.
|
0.0007061 ng/mL
Geometric Coefficient of Variation 30808
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1 and 10Population: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated.
Ctrough was defined as pre-dose concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Pre-Dose Concentration (Ctrough) of PF-07295324 on Days 1 and 10
Day 1
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Concentration (Ctrough) of PF-07295324 on Days 1 and 10
Day 10 (0 hour)
|
0.00010008 ng/mL
Geometric Coefficient of Variation 0
|
0.0003784 ng/mL
Geometric Coefficient of Variation 3451
|
0.0004395 ng/mL
Geometric Coefficient of Variation 8008
|
—
|
—
|
—
|
—
|
—
|
|
Pre-Dose Concentration (Ctrough) of PF-07295324 on Days 1 and 10
Day 10 (12 hour)
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated.
Rac(Cmax) was defined as observed accumulation ratio for Cmax and was determined by Cmax on Day 10/Cmax on Day 1. Cmax was defined as maximum plasma concentration. Accumulation ratios was not calculated due to Day 1 Cmax values below the limit of quantification.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated.
Rac(AUCtau) was defined as observed accumulation ratio for AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts. Rac\[AUCtau\] was calculated by AUCtau on Day 10/AUCtau on Day 1 and accumulation ratios was not calculated due to Day 1 AUCtau values below the limit of quantification.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated. None of the participants had reportable parameter values.
t1/2 was defined as terminal half-life. It was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated.
CL/F was defined as aparent clearance. It was determined by Dose/AUCtau. AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts).
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=1 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=1 Participants
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-07295324 on Day 10
|
NA L/hr
Geometric Coefficient of Variation NA
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful geometric mean and geometric coefficient of variation when sample size was less than 3.
|
—
|
NA L/hr
Geometric Coefficient of Variation NA
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful geometric mean and geometric coefficient of variation when sample size was less than 3.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07295324 and who had at least 1 of the PK parameters of interest calculated. None of the participants had reportable parameter values.
Vz/F was defined as apparant volume of distribution. It was determined by Dose/(AUCtau \* kel). AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts). kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Cmax was defined as maximum plasma concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-07259955 on Days 1 and 10
Day 1
|
0.001161 ng/mL
Geometric Coefficient of Variation 16729163
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-07259955 on Days 1 and 10
Day 10
|
4.942 ng/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Tmax was defined as time to reach maximum observed plasma concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-07259955 on Days 1 and 10
Day 10
|
8.00 hour
Interval 0.0 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-07259955 on Days 1 and 10
Day 1
|
0.0001000 ng*hr/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-07259955 on Days 1 and 10
Day 10
|
46.48 ng*hr/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Cavg was defined as average plasma concentration. It was determined by AUCtau/tau; where tau was the dosing interval and AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cavg of PF-07259955 on Days 1 and 10
Day 10
|
3.873 ng/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1 and 10Population: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Ctrough was defined as pre-dose concentration. It was observed directly from data.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Ctrough of PF-07259955 on Days 1 and 10
Day 1
|
0.0001000 ng/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough of PF-07259955 on Days 1 and 10
Day 10
|
4.077 ng/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Rac(Cmax) was defined as observed accumulation ratio for Cmax and was determined by Cmax on Day 10/Cmax on Day 1. Cmax was defined as maximum plasma concentration.
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=1 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
Rac(Cmax) of PF-07259955 on Day 10
|
NA ratio
Geometric Coefficient of Variation NA
Per the statistical analysis plan, summary statistics were not presented if fewer than 3 participants had reportable parameter values. Data were considered not sufficient to calculate scientifically meaningful geometric mean and geometric coefficient of variation when sample size was less than 3.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
Rac(AUCtau) was defined as observed accumulation ratio for AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts. Accumulation ratios was not calculated due to Day 1 AUCtau values below the limit of quantification.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated. None of the participants had reportable parameter values.
t1/2 was defined as terminal half-life. It was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated.
CL/F was defined as aparent clearance. It was determined by Dose/AUCtau. AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts).
Outcome measures
| Measure |
Cohort 1 PF-07295324 0.12% Ointment BID
n=4 Participants
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-07259955 on Day 10
|
3441 L/hr
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after applicationPopulation: All participants randomly assigned to study intervention who received an application of PF-07259955 and who had at least 1 of the PK parameters of interest calculated. None of the participants had reportable parameter values.
Vz/F was defined as apparant volume of distribution. It was determined by Dose/(AUCtau \* kel). AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts). kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 PF-07295324 0.12% Ointment BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 PF-07295324 Vehicle Ointment BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 PF-07259955 2% Cream BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 PF-07259955 Vehicle Cream BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 PF-07295324 0.12% Ointment BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 PF-07295324 Vehicle Ointment BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 PF-07295324 0.12% Ointment QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 PF-07295324 Vehicle Ointment QD
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-07295324 0.12% Ointment BID
n=4 participants at risk
Healthy participants in Cohort 1 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 1 PF-07295324 Vehicle Ointment BID
n=2 participants at risk
Healthy participants in Cohort 1 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 2% Cream BID
n=4 participants at risk
Healthy participants in Cohort 2 randomized to active received 2% PF-07259955 cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 2 PF-07259955 Vehicle Cream BID
n=2 participants at risk
Healthy participants in Cohort 2 randomized to vehicle received vehicle cream BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 0.12% Ointment BID
n=4 participants at risk
Healthy participants in Cohort 3 randomized to active received 0.12% PF-07295324 ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 3 PF-07295324 Vehicle Ointment BID
n=2 participants at risk
Healthy participants in Cohort 3 randomized to vehicle received vehicle ointment BID on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 0.12% Ointment QD
n=4 participants at risk
Healthy participants in Cohort 4 randomized to active received 0.12% PF-07295324 ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
Cohort 4 PF-07295324 Vehicle Ointment QD
n=2 participants at risk
Healthy participants in Cohort 4 randomized to vehicle received vehicle ointment QD on approximately 20% BSA or 4000 cm\^2 of skin area for 10 days.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Injury, poisoning and procedural complications
Scratch
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
2/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site dryness
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site erythema
|
75.0%
3/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
2/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site irritation
|
75.0%
3/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site pain
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site papules
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
2/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
25.0%
1/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
|
General disorders
Application site pruritus
|
75.0%
3/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
75.0%
3/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
50.0%
1/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/4 • Baseline up to the end of follow up (ie, up to 44 days)
|
0.00%
0/2 • Baseline up to the end of follow up (ie, up to 44 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place