Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
Public ClinicalTrials.gov record NCT02469298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin (GSK1325756) in the Treatment of Healthy Adults With Acute, Uncomplicated Influenza (201682)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02469298
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Interventions
- GSK1325756 (Danirixin) Drug
- Placebo To Match GSK1325756 Drug
- Oseltamivir Phosphate Drug
- Placebo To Match Oseltamivir Phosphate Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2015
- Primary completion
- Apr 24, 2016
- Completion
- Apr 24, 2016
- Last update posted
- Jul 22, 2019
2015 – 2016
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Palmetto Bay | Florida | 33157 | — |
| GSK Investigational Site | Blackfoot | Idaho | 83221 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02469298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02469298 live on ClinicalTrials.gov.