GSK Investigational Site
Syracuse, New York, 13210, United States
NCT Number: NCT02201303
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.
Looking for future studies?
Notify MeUp to 64 year
All sexes
Interventional
Phase 1
Syracuse, New York, 13210, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy Adults
RSV Infected Children
Exclusion criteria
Healthy Adults
RSV Infected Children
Powdered form for in-vitro administration to blood sample
Escalating concentrations of CXCL1 will be added to whole blood in vitro. A CXCL1/CD11b upregulation concentration response curve will determine the concentration to be used in Part 2.
Time frame: Day 1
Blood (1.5 milliliter [mL]) will be collected from a peripheral vein via indwelling catheter or direct venepuncture. Escalating concentrations of danirixin (0.03-100 micromoles) will be added to whole blood in vitro with a fixed concentration of CXCL1 to determine inhibition of Cluster of Differentiation 11b (CD11b) expression on peripheral blood neutrophils analyzed by Fluorescence-Activated Cell sorting (FACs).
Time frame: Day 1
Blood (1.0 mL) will be collected from a peripheral vein via indwelling catheter or direct venepuncture. Escalating concentrations of CXCL1 will be added to whole blood in vitro and CD11b upregulation on peripheral blood neutrophils will be analyzed by FACS
Time frame: Day 1
Inhibition of CD11b upregulation will be evaluated to determine if there is a similar concentration-response relationship between healthy adults and RSV-infected children
GlaxoSmithKline
Industry
A Single-Center In Vitro Study to Evaluate GSK1325756 Inhibition of CD11b Cell Surface Expression in Healthy Adults and Respiratory Syncytial Virus-Infected Children <2 Years (200591)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01905215
Infections, Infections, Respiratory Syncytial Virus
Halifax, Nova Scotia, Canada
View Trial DetailsNCT06573281
Infections, Mononegavirales Infections
Rolling Hills Estates, California, United States
View Trial DetailsNCT04520659
Infections, Mononegavirales Infections
Baltimore, Maryland, United States
View Trial DetailsNCT05765396
COVID-19, COVID-19 Pneumonia
Fort Sam Houston, Texas, United States
View Trial Details