NCT06107036

A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities

Thorough QT Study to Evaluate the Effects of BI 1015550 as Single Doses Following Oral Administration on Cardiac Safety Parameters (Double-blind, Randomized, Placebo-controlled, Five-period Crossover, With Open-label Moxifloxacin as Positive Control) in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of BI 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1015550	BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
DRUG	Moxifloxacin	Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
DRUG	Placebo	Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2023-10-30
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: United Kingdom