At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 47 enrolled
Drug / intervention
BI 409306 +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.
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
In Brief
A Phase 1 clinical trial evaluating BI 409306, Moxifloxacin, and 1 other intervention for Healthy. Completed, enrolled 47 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartMay 2019
Primary CompletionSep 2019
TodayJul 2026
First PostedMay 1, 2019
Enrollment StartMay 9, 2019
Primary CompletionSep 6, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.2 years ago
Interventions
BI 409306drug
Film-coated tablet
Moxifloxacindrug
Film-coated tablet
Placebo matching to BI 409306drug
Film-coated tablet