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

NCT ID: NCT02473640

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-04-30

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).

Conditions

Healthy Volunteers With Ileostomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

150 mg SYN-004

There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.

Group Type: EXPERIMENTAL

SYN-004

Intervention Type: DRUG

Esomeprazole

Intervention Type: DRUG

Ceftriaxone

Intervention Type: DRUG

Interventions

SYN-004

Intervention Type: DRUG

Esomeprazole

Intervention Type: DRUG

Ceftriaxone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theriva Biologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Synthetic Biologics Investigative Site

Edmonton, Alberta, Canada

Synthetic Biologics Investigative Site

Montreal, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28052855 (View on PubMed)

Other Identifiers

SB-1-004-004

Identifier Type: -

Identifier Source: org_study_id