Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers
Status:
Withdrawn
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Helicobacter pylori infection of the gastric epithelium is the most common bacterial
infection worldwide. Its global prevalence is estimated at 50%, though the burden falls
disproportionately on the developing world, where the prevalence in some areas is 80%. H.
pylori infection is generally acquired during childhood, and without specific antibiotic
treatment can persist for life. The infection is generally clinically asymptomatic during
childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic
(although they may transmit the bacteria).
SQ109 is a new, small molecule antibiotic with characteristics that make it particularly
attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable,
acid-stable, has in vitro activity against H. pylori and achieves high intracellular
concentration (which may be important to effect bacterial eradication).
Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this
clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori.
Data from this study will help determine whether larger safety and efficacy studies in
individuals with H. pylori-associated duodenal ulcer disease are warranted.