Study of Danirixin in Japanese Healthy Elderly Male Subjects
Status:
Completed
Trial end date:
2017-07-31
Target enrollment:
Participant gender:
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.