Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
Condition: Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): GSK1325756 (Danirixin); Placebo To Match GSK1325756; Oseltamivir Phosphate; Placebo To Match Oseltamivir Phosphate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use; It will be supplied as capsule shaped white film coated placebo tablet for oral use; It will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use; It will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute, uncomplicated influenza; Danirixin; oseltamivir