Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01209104
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2010-09-23
Brief Title:
Pharmacokinetics and Safety of GSK1325756 in Elderly Subjects and Adult Subjects of in the Fed and Fasted States and in the Presence of a Proton Pump Inhibitors
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single-dose Open Randomized Crossover Investigation of Age Gender Food-effect and Proton-pump Interaction on the Pharmacokinetics of GSK1325756 in Healthy Adult Subjects and a Single-dose Double Blind Parallel-group Placebo- Controlled Investigation of the Pharmacokinetics of GSK1325756
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:
GSK1325756 is a potent competitive selective and reversible CXCR2 receptor antagonist that is being developed as a once-daily oral anti-inflammatory medication for the treatment of chronic obstructive pulmonary disease COPD Selective antagonism of the interaction between CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying inflammation in COPD via the inhibition of neutrophil recruitment and activation The current study explores the effects of age gender and food high fat meal on the pharmacokinetics of GSK1325756
Because a significant proportion of COPD subjects are prescribed proton pump inhibitors PPIs such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease GERD it is important to understand the absorption of the current formulation of GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients taking PPIs Therefore this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756
Because a significant proportion of COPD subjects are prescribed proton pump inhibitors PPIs such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease GERD it is important to understand the absorption of the current formulation of GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients taking PPIs Therefore this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756
Detailed Description:
GSK1325756 is a potent competitive selective and reversible CXCR2 receptor antagonist that is being developed as a once-daily oral anti-inflammatory medication for the treatment of chronic obstructive pulmonary disease COPD Selective antagonism of the interaction between CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying inflammation in COPD via the inhibition of neutrophil recruitment and activation The current study explores the effects of age gender and food high fat meal on the pharmacokinetics of GSK1325756
Because a significant proportion of COPD subjects are prescribed proton pump inhibitors PPIs such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease GERD it is important to understand the absorption of the current formulation of GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients taking PPIs Therefore this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756
Because a significant proportion of COPD subjects are prescribed proton pump inhibitors PPIs such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease GERD it is important to understand the absorption of the current formulation of GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients taking PPIs Therefore this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756
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