Investigation of Topical SB705498 on Healthy Volunteers
A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 on Capsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.|
- Measurement of the area of flare induced by capsaicin as assessed by Laser [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- 2) Average itch over maximum of 15 minutes post application of challenge agent [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- vital sign measurements, ECG, Clinical Laboratory data and Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]safety and tolerability
- Peak itch intensity on 0 to 100 COVAS (Computerised visual analogue scale) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: study population
All subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator
1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.Drug: Placebo
Placebo to match SB705498 will be used in both Part A and Part B of the study.
This study is a two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in healthy volunteers. Part A has been designed to establish whether the topical formulation is capable of delivering SB705498 to the proposed site of action, and to select an appropriate dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a histaminergic and a non-histaminergic pathway, using two different challenge agents; histamine and cowhage. This may provide important information about the role of TRPV1 in pruritus and the therapeutic potential of SB705498.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673529
|GSK Investigational Site|
|Cambridge, United Kingdom, CB2 2GG|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|