At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
LSF emodepside (BAY 44-4400) or matching placebodrug
Likely dose
LSF emodepside (BAY 44-4400) or matching placebo 1mgfrom 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.
A Phase 1, Single-Blind, Randomized, Placebo Controlled, Parallel-Group, Multiple-Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating LSF emodepside (BAY 44-4400) or matching placebo for Filariasis. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFilariasis
CountriesUnited Kingdom
CollaboratorsBayer, Bill and Melinda Gates Foundation
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedDec 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedDec 26, 2017
Enrollment StartNov 14, 2017
Primary CompletionOct 15, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.5 years ago
Interventions
LSF emodepside (BAY 44-4400) or matching placebodrug
Emodepside administered as an LSF oral solution (1mg/mL)