Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers.

ABSTRACT:

Background

Surotomycin, a novel, orally administered, cyclic, lipopeptide antibacterial in development for the treatment of Clostridium difficile-associated diarrhea, has demonstrated minimal intestinal absorption in animal models.

Methods

Safety, tolerability, and plasma pharmacokinetics of single and multiple ascending oral doses (SAD/MAD) of surotomycin in healthy volunteers were characterized in two randomized, double-blind, placebo-controlled, phase 1 studies.

Results

Participants were sequentially enrolled into one of four SAD (500, 1000, 2000, 4000 mg surotomycin) or three MAD (250, 500, 1000 mg surotomycin twice/day for 14 days) cohorts. Ten subjects were randomized 4:1 into each cohort to receive surotomycin or placebo. Surotomycin plasma concentrations rose

SUBMITTER: Chandorkar G 

PROVIDER: S-EPMC5368910 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature