Clinical trial NCT02473640: A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers With Ileostomy
Lead sponsor: Theriva Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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 β-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

Primary outcomes:
measure: Ceftriaxone Concentration in Intestinal Chyme Period 1
timeFrame: 0-8.5 hours
measure: Ribaxamase Concentration in Intestinal Chyme Period 1
timeFrame: 0-8.5 hours
measure: Ceftriaxone Concentration in Intestinal Chyme Period 2
timeFrame: 0-8.5 hours
measure: Ribaxamase Concentration in Intestinal Chyme Period 2
timeFrame: 0-8.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Synthetic Biologics Investigative Site
state: Alberta
city: Montreal
country: Canada
facility: Synthetic Biologics Investigative Site
Study officials:
References:
citation: Kokai-Kun JF, Roberts T, Coughlin O, Sicard E, Rufiange M, Fedorak R, Carter C, Adams MH, Longstreth J, Whalen H, Sliman J. The Oral beta-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02197-16. doi: 10.1128/AAC.02197-16. Print 2017 Mar.