Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02469298
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-04-23
Brief Title:
Safety Tolerability and Clinical Effect of Danirixin in Adults With Influenza
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None