NCT01209104

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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 (PPI's) 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 PPI's. 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 (PPI's) 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 PPI's. Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756.

Conditions

• Nutritional Status

Interventions

Type	Name	Description
DRUG	GSK1325756	100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets
DRUG	GSK1325756	100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets

Timeline

• Start date: 2010-04-14
• Primary completion: 2010-05-24
• Completion: 2010-05-24
• First posted: 2010-09-27
• Last updated: 2017-06-14

Locations

1 site across 1 country: United States