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drugset / Trial / NCT03934203

This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)

NCT03934203 ↗

Phase 1 Completed 47 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2019-05-09
Primary completion
2019-09-06
Completion
2019-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 400 mg Oral
Subject OSORESNONTRINE Small molecule 50 mg Oral
Subject OSORESNONTRINE Small molecule 250 mg Oral

Indications

No indication recorded.