Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01673529
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2012-07-12
Brief Title:
Investigation of Topical SB705498 on Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None