NCT02473640

A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Theriva Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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).

Conditions

• Healthy Volunteers With Ileostomy

Interventions

Type	Name	Description
DRUG	SYN-004
DRUG	Esomeprazole
DRUG	Ceftriaxone

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-06-16
• Last updated: 2018-11-27
• Results posted: 2018-02-19

Locations

2 sites across 1 country: Canada