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Combination therapy GSK2894512 A+ GSK2894512 B · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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...
Combination therapy GSK2894512 A + GSK2894512 B is an investigational small molecule topical treatment being developed by GSK plc for atopic dermatitis, a form of eczema. It combines two cream formulations, GSK2894512 Cream A and GSK2894512 Cream B, and has been studied in a single Phase 1 trial in healthy volunteers.
Combination therapy GSK2894512 A + GSK2894512 B is being developed for atopic dermatitis, also called atopic eczema. The only clinical study of the combination enrolled healthy adult volunteers rather than patients with the condition, so its use in atopic dermatitis remains investigational and has not been established through patient trials.
GSK plc, which trades under the ticker GSK, is the developer of combination therapy GSK2894512 A + GSK2894512 B. The company sponsors the clinical program for the two cream formulations, GSK2894512 Cream A and GSK2894512 Cream B, in atopic dermatitis.
Combination therapy GSK2894512 A + GSK2894512 B is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
Combination therapy GSK2894512 A + GSK2894512 B has been evaluated in one completed Phase 1 trial, NCT02411162, titled A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream. That study enrolled 15 healthy male volunteers aged 18 years and older in the United States.