A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy

Completed · Phase 1/Phase 2

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02419001

Run by

Theriva Biologics, Inc.

People needed

11

Starts

2015-03-01

Expected to finish

2015-10-01

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject has a functioning ileostomy which has been in place for > 3 months.
• Male or female between the ages of 18 and 70 years, inclusive.
• Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.

You may not qualify if…

• 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 weeks prior to the screening visit.

Where it is running

• Study site — Columbus, Ohio, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Montreal, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.