CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Period 1 - Treatment Sequence AB +3 moredrug
Likely dose
Period 1 - Treatment Sequence AB 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02419001
NCT02419001Phase 2Completed
CompareCT.gov

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

Theriva Biologics, Inc.·interventional·Posted Apr 17, 2015·Updated Nov 27, 2018

In Brief

A Phase 2 clinical trial evaluating Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, and 2 other interventions for Healthy Volunteers. Completed, enrolled 11 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartMar 1, 2015
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.2 years ago

Interventions

Period 1 - Treatment Sequence ABdrug

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Period 1 - Treatment Sequence ACdrug

Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004

Period 2 - Treatment Sequence ABdrug

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg

Period 2 - Treatment Sequence ACdrug

Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg