Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02130193
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2013-12-19
Brief Title:
Investigation of Safety Tolerability Pharmacokinetics Pharmacodynamics and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Two Part Phase IIa Randomized Placebo-controlled Study To Investigate The Safety Tolerability Pharmacokinetics Pharmacodynamics and Clinical Efficacy of Oral Danirixin GSK1325756 in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The aim of this First Time in Patient study is to obtain initial information on the safety tolerability pharmacokinetics pharmacodynamics and clinical efficacy of repeat daily administration of danirixin in subjects with symptomatic chronic obstructive pulmonary disease COPD having mild to moderate airflow limitation and are at high risk for future COPD exacerbations
The study will be conducted in two parts Part A will be a two week open label single arm study in patients with COPD to obtain pharmacokinetic data and safety information of repeat dosing of danirixin in the population of interest Approximately 10 subjects will be enrolled in Part A of the study Progression to and dose selection for Part B will occur following review of the data collected in Part A Part B will be a 52-week randomized double-blind sponsor unblind placebo-controlled on top of standard of care parallel group study Part B will evaluate several clinical efficacy assessments related to exacerbations and respiratory symptoms Approximately 100 subjects will be enrolled with a target of 80 subjects completing 52 weeks of danirixin administration
The study will be conducted in two parts Part A will be a two week open label single arm study in patients with COPD to obtain pharmacokinetic data and safety information of repeat dosing of danirixin in the population of interest Approximately 10 subjects will be enrolled in Part A of the study Progression to and dose selection for Part B will occur following review of the data collected in Part A Part B will be a 52-week randomized double-blind sponsor unblind placebo-controlled on top of standard of care parallel group study Part B will evaluate several clinical efficacy assessments related to exacerbations and respiratory symptoms Approximately 100 subjects will be enrolled with a target of 80 subjects completing 52 weeks of danirixin administration
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