Dermatitis, Atopic
Conditions
Keywords
atopic dermatitis, FLIM, chronic plaque psoriasis, healthy volunteers, GSK2894512, Skin residency
Brief summary
This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).
Interventions
DRUGCombination therapy GSK2894512 Cream A + GSK2894512 Cream B
GSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm\^2 of skin.
DRUGCombination therapy Vehicle Cream A + Vehicle Cream B
Vehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied.
Sponsors
Stiefel, a GSK Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Males, between 18 and 45 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Skin tone in the potential test site on the forearm such that erythema and other dermal reactions can be easily visualized, i.e. only Fitzpatrick skin types I (always burns; never tans), II (usually burns; tans with difficulty), III (sometimes mild burn; gradually tans), or IV (rarely burns; tans with ease) will be included. Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure. * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrolment. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residence time in skin following topical application of two formulations of GSK2894512 Cream | Up to Day 15 | Fluorescent lifetime imaging microscopy (FLIM) images will be evaluated to determine if GSK2894512 is detectable in skin. Drug concentrations can be quantified considering the: depth of penetration at each time point and the amount of fluorescence detected. Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) will also be used to measure the concentration of GSK2894512 from biopsies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream | Up to Day 15 | Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate |
| Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream | Up to Day 15 | Single 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval for Bazett's formula (QTcB) intervals |
| Adverse events (AEs) monitoring after two formulations of GSK2894512 cream | Up to Day 15 | An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity, or; is a congenital anomaly/birth defect. |
| Laboratory assessments after two formulations of GSK2894512 cream | Up to Day 15 | Laboratory assessments including haematology, clinical chemistry, and urinalysis |
| Local tolerability assessments after two formulations of GSK2894512 cream | Up to Day 15 | Tolerability will be evaluated on the basis of degree of local irritation. |
| Composite of abbreviated physical examination after two formulations of GSK2894512 cream | Up to Day 15 | Physical examination will include, at a minimum assessments of Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. Height and weight will also be measured and recorded |
Countries
United States
Outcome results
None listed