A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the
Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult
Subjects with a Functioning Ileostomy.
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 70 years,
inclusive, will be enrolled. The entire duration of the study may be up to 64 days (from
Screening to the end-of-study [EOS] visit).
1. The subject has a functioning ileostomy which has been in place for > 3 months.
2. Male or female between the ages of 18 and 70 years, inclusive.
3. Other than a functioning ileostomy, the subject is free from clinically significant
illnesses or disease.
1. Subjects who have active hepatic, small intestine, or biliary tract disease.
2. Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory
3. Subjects with known malignancy requiring treatment < 6 months prior to study
4. Subjects who have, in the opinion of the investigator, significant concurrent medical
5. Subjects who are currently taking concomitant medications which may interfere with
6. 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.
7. Subjects with a known history of allergy to any cephalosporin, penicillin or any
8. Subjects who have known active malabsorption syndromes(s) that, in the judgment of
the investigator, could compromise the objectives of the study.
9. Subjects who have used any oral, intramuscular, or IV anti-microbial medication
during the last 3 weeks prior to the screening visit.