NCT04225078

A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants

A Randomized, Double-blind, Placebo- and Positive-controlled, Single-dose, 4 Way Crossover Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effects of loperamide on QT/ QT interval corrected for heart rate (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Loperamide	Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
OTHER	Placebo	Matching loperamide placebo capsules will be administered orally.
DRUG	Moxifloxacin	Moxifloxacin tablets will be administered orally.

Timeline

• Start date: 2020-01-17
• Primary completion: 2021-12-21
• Completion: 2022-01-12
• First posted: 2020-01-13
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study