Last updated: 07/31/2020 02:40:32

A Single Dose Phase I Exploratory Study in Healthy Volunteers with GSK2894512 Cream

GSK study ID
201661
See study documents
Clinicaltrials.gov ID
NCT02411162
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers
Trial description: 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).
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Residence time in skin following topical application of two formulations of GSK2894512 Cream

Timeframe: Up to Day 15

Secondary outcomes:

Adverse events (AEs) monitoring after two formulations of GSK2894512 cream

Timeframe: Up to Day 15

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

Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream

Timeframe: Up to Day 15

Composite of abbreviated physical examination after two formulations of GSK2894512 cream

Timeframe: Up to Day 15

Laboratory assessments after two formulations of GSK2894512 cream

Timeframe: Up to Day 15

Local tolerability assessments after two formulations of GSK2894512 cream

Timeframe: Up to Day 15

Interventions:
  • Drug: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B
  • Drug: Combination therapy Vehicle Cream A + Vehicle Cream B
    • Enrollment:
    15
    Primary completion date:
    2015-24-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Aneesh Alex, Steve Frey, Hanna Angelene, Craig Neitzel, Joanne Li, Andrew Bower, Darold Spillman Jr, Marina Marjanovic, Eric Chaney, Jeremy Lee Medler, Warren Lee, Lakshmi Vasist, Stephen Boppart, Zane Arp.In situ bio-distribution and residency of a topical anti-inflammatory using fluorescence lifetime imaging microscopy.Br J Dermatol.2018;179(6):1342-1350 DOI: 10.1111/bjd.16992 PMID: 29989149
    Medical condition
    Dermatitis, Atopic
    Product
    tapinarof
    Collaborators
    Not applicable
    Study date(s)
    July 2015 to September 2015
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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)
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Urbana, Illinois, United States, 61801
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-24-09
    Actual study completion date
    2015-24-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 201661 can be found on the GSK Clinical Study Register.
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