Japanese Phase 1 Study of GSK2585823

NCT01428466 | Completed Phase 1

• 1 other identifier: 114849
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-center, partial-blind study to evaluate the dermal irritation potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese healthy male and female volunteers. Finn-Chambers containing no investigational product will be applied in the same manner. Safety will also be assessed by measurement of vital signs, electrocardiograms, safety laboratory data and review of adverse events.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Dermal irritancy (simple patch test)

  Participants will be followed for the duration of hospital stay, an expected average of 22 days.

• Photo allergy and toxicity (Photo patch test)

  Participants will be followed for the duration of hospital stay, an expected average of 22 days.

Secondary Outcomes (2)

• Photo-toxicity and photo-allergy potential (photo-patch test)

  Participants will be followed for the duration of hospital stay, an expected average of 22 days.

• Safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, clinical laboratory safety tests

  Participants will be followed for the duration of hospital stay, an expected average of 22 days.

Study Arms (4)

GSK2585823

EXPERIMENTAL

external preparation

Drug: GSK2585823

Benzoic peroxide 3%

ACTIVE COMPARATOR

external preparation

Drug: Benzoyl peroxide 3%

Benzoic peroxide 5%

ACTIVE COMPARATOR

external preparation

Drug: Benzoyl peroxide 5%

Vehicle

PLACEBO COMPARATOR

external preparation

Other: Vehicle

Interventions

GSK2585823 DRUG

CLDM1%/BPO3%

GSK2585823

Benzoyl peroxide 3% DRUG

Benzoyl peroxide 3%

Benzoic peroxide 3%

Benzoyl peroxide 5% DRUG

Benzoyl peroxide 5%

Benzoic peroxide 5%

Vehicle OTHER

placebo

Vehicle

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as determined by a responsible and experienced physician.
• Japanese healthy male and female subjects aged between 20 and 45 years of age inclusive, at the time of signing the informed consent.
• Asparate aminotransferase(AST), Alanine aminotransferase(ALT) and total bilirubin \< Upper level of normal range
• Non-smoker (never smoked or not smoking for \>6 months with \<10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
• Body Mass Index (BMI) within the range =\>18.5 to \< 25.0 kg/m2 at screening
• A female subject is eligible to participate if she is of:
• Non-childbearing potential.
• Child-bearing potential and agrees to use one of the contraception methods from screening to the follow up examination.
• Capable of giving written informed consent.
• Single QTcB \< 450 msec at screening

You may not qualify if:

• A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antibody and HTLV-1 result at screening.
• A positive for urine drug screening.
• History of regular alcohol consumption within 6 months of the study defined as:
• an average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 g of alcohol: 350 mL of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
• The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
• 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 7 days prior to the first application of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• 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 GSK Medical Monitor, contraindicates their participation.
• The subject has donated a unit of blood "\>400 mL" within the previous 4 months or "\>200 mL" within the previous 1 month.
• Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
• Lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.
• Subjects with clinically significant skin diseases which may contraindicate participation, or interfere with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
• Subjects with a history of hypersensitivity or idiosyncratic reaction to benzoyl peroxide, clindamycin, lincomycin or any study medication components or requiring significant concomitant medications or with diseases affecting evaluation of study medication

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 170-0003, Japan

Location

Related Publications (1)

• Nakahara N, Nohda S, Hirama T. Dermal safety of GSK2585823 in healty Japanese subjects. [J Clin Therapeut Med]. 2012;(September):867-876.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 114849 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: September 5, 2011
• Study Start: November 18, 2010
• Primary Completion: February 15, 2011
• Study Completion: February 15, 2011
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)