Phase 2
N=15
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
Healthy Volunteers With Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT02473640 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Ceftriaxone Concentration in Intestinal Chyme Period 1 — 0.00; 0.00; 5.60; 150.90 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SYN-004 (Drug); Esomeprazole (Drug); Ceftriaxone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theriva Biologics, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ceftriaxone Concentration in Intestinal Chyme Period 1 |
0.00; 0.00; 5.60; 150.90; 231.40; 173.00 | — |
| PRIMARY Ribaxamase Concentration in Intestinal Chyme Period 1 |
0.00; 2; 11; 131; 6727; 56795 | — |
| PRIMARY Ceftriaxone Concentration in Intestinal Chyme Period 2 |
0.00; 0.00; 9.80; 31.70; 42.80; 80.50 | — |
| PRIMARY Ribaxamase Concentration in Intestinal Chyme Period 2 |
0.00; 436; 281; 97745; 66936; 63696 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02473640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.