Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01209052
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2010-09-23
Brief Title:
First Time in Human Study With GSK1325756
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single-centre Double-blind Placebo-controlled Study to Evaluate the Safety Tolerabilty Pharmacokinetics and Pharmacodynamics of Single Oral Ascending Doses and Repeat Oral Doses of GSK1325756 in Healthy Male Subjects
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:
This study aims to investigate the safety tolerability pharmacokinetics and pharmacodynamics of single oral ascending doses and repeat oral doses of GSK1325756 administered to healthy adult male volunteers This study is the First Time in Human study for GSK1325756
Detailed Description:
This study will evaluate the safety tolerability pharmacokineticsPK and pharmacodynamics PD of single and repeat oral doses of GSK1325756 in healthy male volunteer subjects including the assessment of the effect of GSK1325756 on ex vivo C-X-C Motif Ligand 1 CXCL1-induced Cluster of Differentiation 11b CD11b cell surface expression on peripheral blood neutrophils Selective antagonism of the interaction between C-X-C Receptor Type 2 CXCR2 and its various chemokine ligands provides a potential strategy for reducing the underlying inflammation that contributes to the progression of Chronic Obstructive Pulmonary Disease COPD This study is the first administration of GSK1325756 to humans and will be conducted in four cohorts
Cohorts 1 and 2 will comprise of a double-blind placebo-controlled single dose escalation of GSK132576 in healthy adult males in two interlocking cohorts
The data generated from this single dose escalation component of the study safety tolerability and where applicable PK profile and if available PD data will enable decisions regarding progression from one to dose the next higher dose later within Cohorts 1 and 2 This data will also be reviewed in decisions regarding study progression to repeat dosing in Cohorts 3 and 4 and the most suitable doses of GSK1325756 that should be selected for these repeat dose cohorts
Cohorts 1 and 2 will comprise of a double-blind placebo-controlled single dose escalation of GSK132576 in healthy adult males in two interlocking cohorts
The data generated from this single dose escalation component of the study safety tolerability and where applicable PK profile and if available PD data will enable decisions regarding progression from one to dose the next higher dose later within Cohorts 1 and 2 This data will also be reviewed in decisions regarding study progression to repeat dosing in Cohorts 3 and 4 and the most suitable doses of GSK1325756 that should be selected for these repeat dose cohorts
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