A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
Status: | Completed |
---|---|
Conditions: | Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 4/21/2016 |
Start Date: | July 2015 |
End Date: | September 2015 |
Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers
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).
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).
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.
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