CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 77 enrolled
Drug / intervention
Emodepside (BAY 44-4400)drug
Likely dose
Not stated in 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/NCT03383523
NCT03383523Phase 1Completed
CompareCT.gov

Phase1,Randomized,Open-Label,Parallel-Group,Relative Bioavailability Study to Investigate PK,Including Food Effect,Safety and Tolerability of Single Doses of New Immediate Release Tablet Formulations of Emodepside (BAY 44-4400),Compared to Oral Solution,in Healthy Male Subjects

Drugs for Neglected Diseases·interventional·Posted Dec 26, 2017·Updated Mar 9, 2020

In Brief

A Phase 1 clinical trial evaluating Emodepside (BAY 44-4400) for Filariasis. Completed, enrolled 77 participants across 1 site.

Detailed Summary

This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they will be compared to the oral liquid service formulation (LSF) used in the FIH Single Ascending Dose study (DNDi-EMO-001 study) (CT.gov identifier: NCT02661178)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFilariasis
CountriesUnited Kingdom
CollaboratorsBayer, Bill and Melinda Gates Foundation

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartOct 26, 2017
Primary CompletionMar 26, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.5 years ago

Interventions

Emodepside (BAY 44-4400)drug

2 tablets compared to the liquid formulation