NCT03934203

This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

Thorough QT Study to Evaluate the Effects of BI 409306 as Single Dose on Cardiac Safety Parameters in Healthy Male and Female Subjects. A Randomized, Placebo Controlled, Double-blind, Five-period Crossover Study With (Open-label) Moxifloxacin as Positive Control

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to assess the effect of BI 409306 on the QT/QTc interval in healthy male and female volunteers as measured by the QTcF change from baseline compared with placebo. Secondary objectives are to show the assay sensitivity of the trial, by reproducing the typical effect of the positive control moxifloxacin on the QT/QTc interval, and to assess the effect of BI 409306 on heart rate.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 409306	Film-coated tablet
DRUG	Moxifloxacin	Film-coated tablet
DRUG	Placebo matching to BI 409306	Film-coated tablet

Timeline

• Start date: 2019-05-09
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2019-05-01
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

1 site across 1 country: Germany