Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03136380
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2017-04-17
Brief Title:
Study of Danirixin in Japanese Healthy Elderly Male Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Centre Double Blind Sponsor Open Placebo Controlled 3-Period Crossover Ascending Dose Study in Japanese Healthy Elderly Male Subjects to Evaluate the Safety Tolerability and Pharmacokinetics of Danirixin in the Fed State Part1 and an Open Label 2-way Crossover to Evaluate Food Effect on the Pharmacokinetics of Danirixin Part2
Status:
COMPLETED
Status Verified Date:
2019-01
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:
Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease COPD The aim of the study is to assess the safety tolerability and pharmacokinetics PK in healthy Japanese subjects over the age of 65 years inclusive The study will be conducted in two parts Part 1 will be a double blind placebo-controlled 3-period crossover ascending single oral dose administration of GSK1325756H Hydrobromide Salt Tablet Formulations of Danirixin 10 50 and 100 milligram mg in the fed condition Part 2 will be an open label 2-period crossover single oral dose of GSK1325756H 50 mg in fed and fasted state This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in population of healthy elderly subjects and also contribute to the selection of appropriate dosing for Phase IIa study in Japan
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None