At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
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
Timeline
Interventions
BI 1015550 administered as low (L), and high (H), dose. Oral tablet.
Moxifloxacin was used as positive control, given as a high dose. Oral tablet.
Placebo was administered as low (P1), matching the low-dose nerandomilast group, and as high (P2), matching the high-dose neradnomilast group. Oral tablet.