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

Completed Phase 1 Last updated 14 June 2017

What this trial tests

Phase 1 trial testing GSK1325756 in Nutritional Status in 32 participants. Completed in 24 May 2010.

Timeline

14 April 2010

Primary endpoint
24 May 2010

24 May 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	14 April 2010
Primary completion	24 May 2010
Estimated completion	24 May 2010
Sites	1 location across United States

Drugs / interventions tested

• GSK1325756 — full drug profile →
• GSK1325756 — full drug profile →

Conditions studied

• Nutritional Status — all drugs for Nutritional Status →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 40 to 80, any sex, with Nutritional Status. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
   Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
2. Role of chemokine systems in cancer and inflammatory diseases.
   Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
3. The pharmacokinetics and pharmacodynamics of danirixin (GSK1325756)--a selective CXCR2 antagonist --in healthy adult subjects.
   Miller BE, Mistry S, Smart K, Connolly P, et al · · 2015 · cited 42× · PMID 26092545 · DOI 10.1186/s40360-015-0017-x
4. Therapeutic inhibition of CXCR1/2: where do we stand?
   Sitaru S, Budke A, Bertini R, Sperandio M. · · 2023 · cited 40× · PMID 37249756 · DOI 10.1007/s11739-023-03309-5
5. Significance of the IL-8 pathway for immunotherapy.
   Gonzalez-Aparicio M, Alfaro C. · · 2020 · cited 37× · PMID 31860375 · DOI 10.1080/21645515.2019.1696075