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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Arm | Experimental | In Cohort 1, study medication (Cream A, 1%) will be applied as a thin layer onto a predefined area of the volar region of the forearm that is large enough to image and collect 3 biopsies (4 mm per biopsy). Vehicle will be applied on Day 1 only, onto a symmetrical location on the opposite forearm from Cream A. In cohort 2, subjects will be enrolled to evaluate Cream A (1%) and a different GSK2894512 Cream, Cream B (1%). Cream A, 1% and Cream B, 1% will be applied as a thin layer to the opposite forearms of the subject. Vehicle will be applied only on Day 1 to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied. Both Cream A and Cream B will continue to be applied OD to the same area of the same forearm for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy GSK2894512 Cream A + GSK2894512 Cream B | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Residence time in skin following topical application of two formulations of GSK2894512 Cream | 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. | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) monitoring after two formulations of GSK2894512 cream | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Urbana | Illinois | 61801 | United States |
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| Label | URL |
|---|---|
| Results for study 201661 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Combination therapy Vehicle Cream A + Vehicle Cream B | Drug | 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. |
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| Up to Day 15 |
| Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream | 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 | Up to Day 15 |
| Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream | 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 | Up to Day 15 |
| Composite of abbreviated physical examination after two formulations of GSK2894512 cream | Physical examination will include, at a minimum assessments of Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. Height and weight will also be measured and recorded | Up to Day 15 |
| Laboratory assessments after two formulations of GSK2894512 cream | Laboratory assessments including haematology, clinical chemistry, and urinalysis | Up to Day 15 |
| Local tolerability assessments after two formulations of GSK2894512 cream | Tolerability will be evaluated on the basis of degree of local irritation. | Up to Day 15 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |