drugset / Trial / NCT01262885

A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects

NCT01262885

Phase 1 Completed 84 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole hydrochloride) is a Gram negative antibacterial compound currently in development for the treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae, and Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg, b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized, placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of oral GSK2251052.

Timeline

Start
2010-10-07
Primary completion
2011-08-25
Completion
2011-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Epetraborole Small molecule 500 mg Oral
Subject Epetraborole Small molecule 1000 mg Oral
Subject Epetraborole Small molecule 2000 mg Oral