Community-acquired Infection Clinical Trial
Official title:
An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult Subjects
GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that
inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with
tRNA and is currently in development for the treatment of hospital acquired Gram-negative
infections (including E. coli, K. pneumoniae, and Enterobacter spp.).
This is an open-label, randomized, single period, parallel-cohort pharmacokinetic study to
evaluate serum and pulmonary pharmacokinetics following single dose and multiple dose
administration of intravenous GSK2251052. In Cohort 1, approximately 15 healthy adult
subjects will be randomized to receive a single IV dose of GSK2251052 1500 mg in the fasted
state. Following the dose, bronchoalveolar lavage (BAL) fluid and serial plasma samples will
be collected for determination of GSK2251052 parent and metabolite concentrations. In Cohort
2, approximately 15 healthy adult subjects will receive GSK2251052 1500 mg IV BID x 5 doses
(Cohort 2). Following the last dose in the fasted state, bronchoalveolar lavage (BAL) fluid
and serial plasma samples will be collected for determination of GSK2251052 parent and
metabolite concentrations. Vital signs, ECGs, and adverse events will be monitored throughout
the study. A follow up visit will occur 10 to 14 days after the last dose of study drug.
n/a
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