A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects with functioning ileostomies who are between the ages of 18 and 80 years, inclusive, will be enrolled. The entire duration of the study may be up to 63 days (from Screening to the end-of-study \[EOS\] visit).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Synthetic Biologics Investigative Site
Edmonton, Alberta, Canada
Synthetic Biologics Investigative Site
Montreal, Canada
Ceftriaxone Concentration in Intestinal Chyme Period 1
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Time frame: 0-8.5 hours
Ribaxamase Concentration in Intestinal Chyme Period 1
Concentrations of ribaximase (SYN-004) in intestinal chyme
Time frame: 0-8.5 hours
Ceftriaxone Concentration in Intestinal Chyme Period 2
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Time frame: 0-8.5 hours
Ribaxamase Concentration in Intestinal Chyme Period 2
Concentrations of ribaximase (SYN-004) in intestinal chyme
Time frame: 0-8.5 hours
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