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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Synthetic Biologics Inc.
• Treatments: Ceftriaxone; Esomeprazole

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