NCT02419001

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Theriva Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Period 1 - Treatment Sequence AB	Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
DRUG	Period 1 - Treatment Sequence AC	Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
DRUG	Period 2 - Treatment Sequence AB	Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
DRUG	Period 2 - Treatment Sequence AC	Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-04-17
• Last updated: 2018-11-27
• Results posted: 2017-01-11

Locations

3 sites across 2 countries: United States, Canada