To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944
Status:
Completed
Trial end date:
2013-12-21
Target enrollment:
Participant gender:
Summary
Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations
in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid
(ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and
alveolar macrophages represent an ideal estimate of concentrations at the site of infection
and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial
concentrations via BAL is not routine in clinical practice due to its complex methodology and
poor patient tolerability. This study will evaluate intrapulmonary and plasma
pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a
Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following
intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate
the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each
part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed
initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are
necessary to adequately model the pulmonary pharmacokinetic profile.