A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02411162|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B Drug: Combination therapy Vehicle Cream A + Vehicle Cream B||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers|
|Actual Study Start Date :||July 7, 2015|
|Actual Primary Completion Date :||September 24, 2015|
|Actual Study Completion Date :||September 24, 2015|
Experimental: Open Label Arm
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.
Drug: Combination 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.
Drug: Combination 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.
- Residence time in skin following topical application of two formulations of GSK2894512 Cream [ Time Frame: 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.
- Adverse events (AEs) monitoring after two formulations of GSK2894512 cream [ Time Frame: 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.
- Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream [ Time Frame: 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 [ Time Frame: 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
- Composite of abbreviated physical examination after two formulations of GSK2894512 cream [ Time Frame: 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
- Laboratory assessments after two formulations of GSK2894512 cream [ Time Frame: Up to Day 15 ]Laboratory assessments including haematology, clinical chemistry, and urinalysis
- Local tolerability assessments after two formulations of GSK2894512 cream [ Time Frame: Up to Day 15 ]Tolerability will be evaluated on the basis of degree of local irritation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411162
|United States, Illinois|
|GSK Investigational Site|
|Urbana, Illinois, United States, 61801|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|