NCT01673529

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 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers.

Detailed description

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	SB705498	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.

Timeline

• Start date: 2012-07-17
• Primary completion: 2012-10-04
• Completion: 2012-10-04
• First posted: 2012-08-28
• Last updated: 2017-06-09

Locations

1 site across 1 country: United Kingdom