Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
Status:
Completed
Trial end date:
2016-04-25
Target enrollment:
Participant gender:
Summary
Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient
study evaluating the safety, tolerability and clinical effect of danirixin or danirixin +
oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in
otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a
selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits
neutrophil transmigration and activation to areas of inflammation. The study endpoints are
intended to test the hypothesis that inhibition of neutrophil activation by approximately
50-60% (as previously measured by cluster of differentiation [CD11b] expression in response
to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not
impact safety parameters or worsen clinical manifestations of disease, disease-related events
of interest, or viral load, and may possibly improve these parameters when administered
within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the
safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in
combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated
influenza prior to future evaluation in hospitalized patients with complicated influenza. The
primary objective is to assess safety and tolerability of DNX with and without a
neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital
signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an
assessment of disease related events (DREs) of interest and associated antibiotic use. The
Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document
patient reported outcomes (PROs). The screening visit in Australia will be composed of a
pre-screen for influenza infection with an influenza rapid antigen test followed by a screen
for the remaining eligibility criteria for those subjects with a positive result on the
influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health
Private Limited.