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

Healthy Volunteers With Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473640
• Other study ID #: SB-1-004-004
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2018
• Source: Synthetic Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The subject has a functioning ileostomy that has been in place for = 3 months.

• The subject is male or female between the ages of 18 and 80 years, inclusive.

• Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.

Exclusion Criteria:

• Subjects who have active hepatic, small intestine, or biliary tract disease.

• Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease.

• Subjects with known malignancy requiring treatment < 6 months prior to study screening.

• Subjects who have, in the opinion of the investigator, significant concurrent medical illness.

• Subjects who are currently taking concomitant medications which may interfere with study evaluation.

• Subjects who have received an investigational drug within 30 days or within a time period consistent with a washout period of 5 half-lives, whichever is longer, of the first dose of ceftriaxone.

• Subjects with a known history of allergy to any cephalosporin, penicillin or any ß-lactam antibiotic.

• Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study.

• Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 week

Related Conditions & MeSH terms

• Healthy Volunteers With Ileostomy

Intervention

Drug:
• SYN-004

• Esomeprazole

• Ceftriaxone

Locations

Country	Name	City	State
Canada	Synthetic Biologics Investigative Site	Edmonton	Alberta
Canada	Synthetic Biologics Investigative Site	Montreal

Sponsors (1)

Lead Sponsor	Collaborator
Synthetic Biologics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ceftriaxone Concentration in Intestinal Chyme Period 1	Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.	0-8.5 hours
Primary	Ribaxamase Concentration in Intestinal Chyme Period 1	Concentrations of ribaximase (SYN-004) in intestinal chyme	0-8.5 hours
Primary	Ceftriaxone Concentration in Intestinal Chyme Period 2	Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.	0-8.5 hours
Primary	Ribaxamase Concentration in Intestinal Chyme Period 2	Concentrations of ribaximase (SYN-004) in intestinal chyme	0-8.5 hours