NCT02201303

Evaluation of Danirixin (GSK1325756) Inhibition of CD11b Cell Surface Expression

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing Danirixin in Infections, Respiratory Syncytial Virus in 40 participants. Completed in 2 July 2015.

Timeline

13 January 2014

Primary endpoint
2 July 2015

2 July 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	40
Start date	13 January 2014
Primary completion	2 July 2015
Estimated completion	2 July 2015
Sites	1 location across United States

Drugs / interventions tested

• Danirixin — full drug profile →
• CXCL1

Conditions studied

• Infections, Respiratory Syncytial Virus — all drugs for Infections, Respiratory Syncytial Virus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Under 64, any sex, with Infections, Respiratory Syncytial Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to determine danirixin (GSK1325756) concentrations required to inhibit neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected children \<2 years and healthy adults. The study will evaluate differences in neutrophil activation between RSV-infected children \<2 years and healthy adults with escalating concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited by danirixin. This study will guide dose prediction to inhibit specific percentages of neutrophils in future pediatric RSV-infection studies. This single-center, in vitro study will consist of 2 parts. Approximately 24 subjects will be enrolled, including 12 healthy adults and 12 RSV-infected children \<2 years.

Publications & conference data

8 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. Neutrophils in respiratory syncytial virus infection: A target for asthma prevention.
   Geerdink RJ, Pillay J, Meyaard L, Bont L. · · 2015 · cited 85× · PMID 26277597 · DOI 10.1016/j.jaci.2015.06.034
4. Wound healing and cancer stem cells: inflammation as a driver of treatment resistance in breast cancer.
   Arnold KM, Opdenaker LM, Flynn D, Sims-Mourtada J. · · 2015 · cited 84× · PMID 25674014 · DOI 10.4137/cgm.s11286
5. 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
6. The Contribution of Neutrophils to the Pathogenesis of RSV Bronchiolitis.
   Sebina I, Phipps S. · · 2020 · cited 37× · PMID 32726921 · DOI 10.3390/v12080808
7. Significance of the IL-8 pathway for immunotherapy.
   Gonzalez-Aparicio M, Alfaro C. · · 2020 · cited 37× · PMID 31860375 · DOI 10.1080/21645515.2019.1696075
8. The Clinical Significance and Role of CXCL1 Chemokine in Gastrointestinal Cancers.
   Korbecki J, Bosiacki M, Barczak K, Łagocka R, et al · · 2023 · cited 31× · PMID 37408240 · DOI 10.3390/cells12101406