CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 79 enrolled
Drug / intervention
emodepside (BAY 44-4400) +1 moredrug
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/NCT02661178
NCT02661178Phase 1Completed
CompareCT.gov

A Phase 1, Blinded, Randomized, Placebo Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects

Drugs for Neglected Diseases·interventional·Posted Jan 22, 2016·Updated Apr 13, 2020

In Brief

A Phase 1 clinical trial evaluating emodepside (BAY 44-4400) and placebo for Healthy Volunteers. Completed, enrolled 79 participants across 1 site.

Detailed Summary

This study will investigate the safety, tolerability, and pharmacokinetics of single ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also conduct an exploratory investigation of the relative bioavailability of emodepside administered as tablets and determine the effect of food on the pharmacokinetics.

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 22, 2016
Enrollment StartDec 1, 2015
Primary CompletionMar 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.4 years ago

Interventions

emodepside (BAY 44-4400)drug

placebodrug