This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Results from this study will be considered when selecting the concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30 evaluable subjects complete the study. The total duration of subject participation may be up to 50 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% \[5 milligram (mg)/gram (g)\], 1% \[10 mg/g\], and 2% \[20 mg/g\]).
Vehicle cream does not contain any active pharmaceutical ingredient.
Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Hamburg, Germany
Mean cumulative irritation score
It is the sum of dermal response irritation scores from Day 2 through Day 22 divided by the number of non-missing observations
Time frame: 21 Days
Total cumulative irritation score
It is the sum of dermal response irritation scores from Day 2 through Day 22
Time frame: 21 Days
Incidence of adverse events (AEs) and treatment-related AEs
All AEs and serious adverse events will be collected from the time a subject consents to participate in the study through the final study visit
Time frame: Up to Day 22
Change from baseline in vital signs
Vital signs include heart rate, blood pressure, and oral temperature
Time frame: Screening, Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20 and Day 22
Change from baseline in clinical laboratory parameters
Laboratory parameters include haematology and, clinical chemistry tests
Time frame: Screening, Day 11 (+/-2 days) and Day 22
Change from baseline in electrocardiogram (ECG) findings
Single 12-lead ECGs will be obtained using an ECG machine to monitor cardiac safety
Time frame: Screening, Day 11 (+/-2 days) and Day 22 (+/-2 days)
Plasma trough concentrations of GSK2894512
Trough concentration is the minimum concentration of GSK2894512 observed after its administration and just prior to the administration of a subsequent dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Negative control contains petrolatum.
Time frame: Day 11 (+/- 2 days) and Day 22