NCT06070597

A Study in Healthy People to Test Whether Iclepertin Has an Effect on Cardiac Safety

Effects of Iclepertin on the QT Interval Following Oral Administration in Healthy Male and Female Subjects (a Double-blind, Randomised, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial, With Moxifloxacin as Positive Control)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. using the method of Fridericia or Bazett interval and other ECG parameters.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Iclepertin	Iclepertin
DRUG	Iclepertin Placebo	Placebo to Iclepertin
DRUG	Moxifloxacin	Moxifloxacin
DRUG	Moxifloxacin Placebo	Placebo Moxifloxacin

Timeline

• Start date: 2024-01-25
• Primary completion: 2024-06-05
• Completion: 2024-06-05
• First posted: 2023-10-06
• Last updated: 2024-07-09

Locations

1 site across 1 country: Germany