Clinical trial NCT02411162: A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
Official title: Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
FLIM
chronic plaque psoriasis
healthy volunteers
GSK2894512
Skin residency
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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).


Eligibility criteria: 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 monitoring.
* Skin tone in the potential test site on the forearm such that erythema and other dermal reactions can be easily visualized, i.e. only Fitzpatrick skin types I (always burns; never tans), II (usually burns; tans with difficulty), III (sometimes mild burn; gradually tans), or IV (rarely burns; tans with ease) will be included. Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure.
* A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrolment.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria:

* Alanine aminotransferase (ALT) and bilirubin \>1.5 x upper limit of normal (ULN) (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Corrected QT interval (QTc) \>450 milliseconds (msec)
* Concurrent conditions and history of diseases: Immunocompromized (eg, lymphoma, acquired immune deficiency syndrome (AIDS), Wiskott-Aldrich Syndrome or have a history of malignant disease within 5 years before the baseline visit, with the exception of basal and squamous cell cancers; Active acute bacterial, fungal or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox); Any other concomitant skin disorder (e.g., generalized erythroderma such as Netherton's Syndrome, atopic dermatitis or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the test site evaluation or contraindicate participation; clinical signs of infection (viral, fungal or bacterial) within the treatment areas; other types of skin disease that may impact evaluation.
* Inability to evaluate the skin at and around the potential test sites on the forearms due to sunburn, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
* Chronic or acute infection requiring treatment with systemic antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the baseline visit, or superficial skin infections within 1 week before the screening visit.
* Planning a significant exposure to ultraviolet (UV) radiation (sun-bathing or tanning).
* Planning to use a sauna during the duration of the study or intending to swim more than once a week.
* Participation in a clinical drug or device research study within the previous 30 days.
* History of sensitivity to any of the study medications, local anesthesia, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Concomitant Medications: Investigational products and topical medications or products (including but not limited to self-tanning products, waxing products, benzoyl peroxide, salicylic acid, or sulphur) in the areas of testing.
* Contraindications: History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. . For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded.
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Primary outcomes:
measure: Residence time in skin following topical application of two formulations of GSK2894512 Cream
timeFrame: Up to Day 15
Secondary outcomes:
measure: Adverse events (AEs) monitoring after two formulations of GSK2894512 cream
timeFrame: Up to Day 15
measure: Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream
timeFrame: Up to Day 15
measure: Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream
timeFrame: Up to Day 15
measure: Composite of abbreviated physical examination after two formulations of GSK2894512 cream
timeFrame: Up to Day 15
measure: Laboratory assessments after two formulations of GSK2894512 cream
timeFrame: Up to Day 15
measure: Local tolerability assessments after two formulations of GSK2894512 cream
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: Urbana
country: United States
facility: GSK Investigational Site
state: Illinois
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: