Skin Irritation Study of GSK2894512 Cream

NCT ID: NCT02637206

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-27
• Study Completion Date: 2015-12-02

Brief Summary

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 (Single Application)

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).

Group Type: EXPERIMENTAL

GSK2894512 Cream

Intervention Type: 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.

Vehicle Cream

Intervention Type: 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.

Empty Patch

Intervention Type: DRUG

Empty patches without any ingredients will be used as negative control.

Part 2 (Repeat Application)

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.

Group Type: EXPERIMENTAL

GSK2894512 Cream

Intervention Type: 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.

Vehicle Cream

Intervention Type: 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.

Empty Patch

Intervention Type: DRUG

Empty patches without any ingredients will be used as negative control.

Interventions

GSK2894512 Cream

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.

Intervention Type: DRUG

Vehicle Cream

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.

Intervention Type: DRUG

Empty Patch

Empty patches without any ingredients will be used as negative control.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Japanese males and females aged between 20 and 64 years of age inclusive, at the time of signing the informed consent.

Exclusion Criteria

• Healthy skin in the potential test site on the back such that erythema and other dermal reactions can be easily visualized.
• Body Mass Index within the range 18.5 - 24.9 kilogram per square meter (kg/m^2,inclusive) and less than 25.0 kg/m^2.
• A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea with simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter and estradiol < 40 picograms per milliliter (<147 picomole per liter).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <= 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
• Based on single QTc values: QT interval corrected for heart rate according to Fridericia's formula (QTcF) < 450 milliseconds; QTcF < 480 msec in subjects with Bundle Branch Block.

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• History of known or suspected intolerance to any of the ingredients of the study products, adhesive tape/plaster, or the test patches.
• Subjects with inherent sensitivity to sun or history of photosensitivity.
• Inability to evaluate the skin at and around the potential test sites on the back due to sunburns, unevenness in skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
• Clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations.
• Considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk.
• A positive pre-study syphilis, Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antigen antibody or Human T-cell Lymphotropic Virus-1 result of screening.
• A positive pre-study drug screen.
• The subject has donated a unit of blood ">400 milliliter (mL)" within the previous 4 months or ">200 mL" within the previous 1 month prior to the first dosing day.
• The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months prior to the first dosing day.
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• The subject planned to concurrently participate in another clinical study or post-marketing study.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first application of study medication.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fukuoka, , Japan

Countries

Japan

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Other Identifiers

200920

Identifier Type: -

Identifier Source: org_study_id