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

NCT02419001 ↗

Phase 1/2 Completed 11 enrolled Theriva Biologics, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2015-03
Primary completion: 2015-09
Completion: 2015-10

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftriaxone	Other / unclassified	1 g	Intravenous
Subject	Ribaxamase	Monoclonal antibody	75 mg	Oral
Subject	Ribaxamase	Monoclonal antibody	150 mg	Oral

Indications

No indication recorded.