CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
BI 1015550 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06107036
NCT06107036Phase 1Completed

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

Boehringer Ingelheim·interventional·Posted Oct 30, 2023·Updated Nov 28, 2025

In Brief

A Phase 1 clinical trial evaluating BI 1015550, Moxifloxacin, and 1 other intervention for Healthy. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedOct 30, 2023
Enrollment StartMar 6, 2024
Primary CompletionJul 25, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.7 years ago

Interventions

BI 1015550drug

BI 1015550 administered as low (L), and high (H), dose. Oral tablet.

Moxifloxacindrug

Moxifloxacin was used as positive control, given as a high dose. Oral tablet.

Placebodrug

Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.