NCT03012828

Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Potential Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effect of a single oral dose of moxidectin on the QT interval associated with moxidectin plasma concentrations. The effect of moxidectin on other ECG intervals, and on safety, will also be assessed, as will preliminary pharmacokinetics and metabolism

Detailed description

Moxidectin is being developed as a treatment for Onchocerciasis (river blindness), a serious, debilitating, disease caused by a parasitic worm, Onchocerca volvulus. Five dose levels of moxidectin will be administered to healthy volunteers and ECG assessments undertaken at pre-specified pharmacokinetic time points to correlate QT interval with moxidectin concentration in plasma.

Conditions

• QT Effects in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Moxidectin	Moxidectin is a broad spectrum macrocyclic lactone endectocide
OTHER	Placebo

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2017-01-06
• Last updated: 2019-03-14
• Results posted: 2019-03-14

Locations

1 site across 1 country: United States