NCT03383523

Relative Bioavailability Study of Emodepside IR-tablets and Solution

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Detailed description

There is an urgent need for a macrofilaricidal drug, killing or sterilizing permanently O. volvulus adult worms, which could be used in individual case management and, after appropriate testing, as an alternative drug to ivermectin in MDA programs. Emodepside is a promising candidate to kill the adult and sexually mature O. volvulus. Emodepside was shown to be macrofilaricidal against a variety of filarial nematodes and is a registered drug for animal health, commercialized by Bayer AG under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). A first-in-human (FIH) double-blind, placebo-controlled study of single ascending doses of emodepside in healthy Caucasian men has been conducted and the preliminary results are favourable, and support continuing the Phase I development program. For this reason, new tablet formulations have been developped and the present study will evaluate bioavailability, PK safety and tolerability, and as well food effect of single doses of 2 new immediate release (IR)-tablet formulations of emodepside compared to the oral liquid service formulation (LSF) used in the FIH study.

Conditions

• Filariasis

Interventions

Type	Name	Description
DRUG	Emodepside (BAY 44-4400)	2 tablets compared to the liquid formulation

Timeline

• Start date: 2017-10-26
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2017-12-26
• Last updated: 2020-03-09
• Results posted: 2020-03-09

Locations

1 site across 1 country: United Kingdom