This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)
Status:
Completed
Trial end date:
2019-09-06
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
BI 409306 Moxifloxacin Norgestimate, ethinyl estradiol drug combination