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GSK2894512 is a novel anti-inflammatory agent that is currently under development for the topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese volunteers. Part 2 of this study will assess skin irritation following repeat application at 0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6 healthy Japanese volunteers. The study will have Screening visit which will occur within 30 days from the Day 1 visit of each part. Eligible subjects will be able to participate either of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and repeat application in Japanese subjects. Results from this study will enable further clinical investigation in the Japanese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Single Application) | Experimental | All subjects will have two sets (left and right) of 4 semi-occlusive test patches applied to randomized test sites on their upper backs on Day 1. Test patches on left back will be for simple-patch test and those on right back will be for photo-patch test. Each set will consist of approximately 150 micro liter (0.15 mL) of the following study treatments: GSK2894512 0.5% cream, GSK2894512 1% cream, placebo (cream vehicle without the active ingredient) and an empty patch. The test patches will be applied for 24 hrs (photo-patch test) or 48 hrs (simple-patch test). |
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| Part 2 (Repeat Application) | Experimental | All subjects will have repeat applications of GSK2894512 0.5%, 1% cream and placebo twice a day for 7 days on both side (left and right, 3 in total) of their upper back (approximately 5 centimeter (cm) in diameter >10 cm away from another application area) under non-occlusive conditions and covered with gauze using adhesive. GSK2894512 0.5% and 1% cream and placebo will be randomized according to the randomization code in the same manner as Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2894512 Cream | Drug | GSK2894512 cream supplied will be white to off-white cream packaged in 28-gram laminate tubes of 2 concentrations: 0.5% and 1%, to be applied topically. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1-Positive rate of skin irritability as assessed by simple-patch test following single application of GSK2894512 cream | Each test site for the simple-patch test will be evaluated at 30 minutes (min) and 24 hours (hrs) after removal of medication (48.5 hr and 72 hrs after application, respectively) based on the following criteria proposed by the patch test study group in Japan: no reaction (-); weak erythema (+-); erythema (+); erythema + edema (++); erythema + edema + papules, or vesicles (+++); bullae (++++). Except no reaction (-) and weak erythema (+-), rest all findings from simple-patch test will be considered as positive. | Up to Day 4 |
| Part 1-Positive rate of photo-urticaria reaction as assessed by photo patch test following single application of GSK2894512 cream | For the photo-patch test, 4 test patches (right back) will be removed 24 hrs after application and the test sites will be exposed to 6.0 joule per square centimeter of ultraviolet A. Each test site will be evaluated at 30 minutes from the irradiation to determine whether there is photo-urticaria or not (i.e positive or negative). | Day 2 |
| Part 1-Positive rate of photo-toxicity as assessed by photo patch test following single application of GSK2894512 cream | Post photo-urticaria evaluation, the test sites will be re-covered with empty patches, that will be removed at 24 hrs after removal of medication. The test sites will be evaluated at 30 min and 24 hrs after empty patches removal (48.5 and 72 hrs after application, respectively). Assessment Criteria includes: no reaction or similar to the non irradiation site (-); Slightly stronger than the non irradiation site (+-);Definitely stronger than the non irradiation site (+); 2 ranks stronger than the non irradiation site according to the criteria in Japan (++); 3 ranks stronger than the non irradiation site according to the criteria in Japan (+++). Test results of more than or equal to +- will be considered as positive. | Up to Day 4 |
| Part 2- Positive rate of Skin irritability following repeat application of GSK2894512 cream |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of subject with adverse events | An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | From Day 1 to Day 8 |
| Part 2: Number of subject with adverse events |
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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 | Fukuoka | 812-0025 | Japan |
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| Label | URL |
|---|---|
| Results for study 200920 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200920 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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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| Vehicle Cream | Drug | Vehicle Cream (placebo cream without active ingredient) supplied will be white to off-white cream packaged in 28-gram laminate tubes, to be applied topically. |
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| Empty Patch | Drug | Empty patches without any ingredients will be used as negative control. |
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Each test site will be evaluated at 30 min after removal of medication based on the following criteria proposed by the patch test study group in Japan: no reaction (-); weak erythema (+-); erythema (+); erythema + edema (++); erythema + edema + papules, or vesicles (+++); bullae (++++). Except no reaction (-) and weak erythema (+-), rest all findings from simple-patch test will be considered as positive. |
| Day 1 to Day 8 |
| Part 2- Skin observation (subjective symptom) | At each application site 2 hours following application of study drugs, skin observation (subjective symptom) from application to judgement (2 hours) will be heard from subjects. Symptoms will be recorded as a score ranging from 0-4, where 0=Normal, no discomfort; 1=an awareness, but no discomfort and no intervention required; 2=a noticeable discomfort that causes intermittent awareness; 3=a noticeable discomfort that causes intermittent awareness and interferes occasionally with normal daily activities; 4=a definite continuous discomfort that interferes with normal daily activities. | Day 1 to Day 7 |
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| From Day 1 to Day 15 |
| Part 1:Safety as assessed by systolic and diastolic blood pressure measurements | Blood pressure measurements will be measured in supine position after 5 min rest. | Day -1 to Day 8 |
| Part 2: Safety as assessed by systolic and diastolic blood pressure measurements | Blood pressure measurements will be measured in supine position after 5 min rest. | Day -1 to Day 15 |
| Part 1:Safety as assessed by pulse rate measurement | Pulse rate measurement will be measured in supine position after 5 min rest. | Day -1 to Day 8 |
| Part 2: Safety as assessed by pulse rate measurement | Pulse rate measurement will be measured in supine position after 5 min rest. | Day -1 to Day 15 |
| Part 1:Safety as assessed by12-lead electrocardiogram (ECG) | ECGs will be taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT and QTc intervals. | Day -1 to Day 8 |
| Part 2: Safety as assessed by12-lead ECG | ECGs will be taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. | Day -1 to Day 15 |
| Part 1:Safety as assessed by clinical laboratory test | Clinical laboratory parameters include: Hematology, clinical chemistry and urinalysis parameters | Day -1, 4 and 8 |
| Part 2: Safety as assessed by clinical laboratory test | Clinical laboratory parameters include: Hematology, clinical chemistry and urinalysis parameters | Day -1, 4, 8 and 15 |
| Part 2: Plasma concentration of GSK2894512 | Day 1 and Day 7 (pre-dose, 2, 4 hours post-AM application); Day 3 and Day 5 (pre-dose of AM application) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200920 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |