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

NCT02419001 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-11-27

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Theriva Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kaleko, M.D. · Synthetic Biologics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02419001 on ClinicalTrials.gov