drugset / Trial / NCT02438683

BI 409306 Cardiac Safety Trial in Healthy Volunteers

NCT02438683

Phase 1 Completed 20 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

This trial will be conducted to further evaluate, in a controlled setting, potential cardiac effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting and exercise conditions. Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound. This trial will be conducted to further evaluate, in a controlled setting, potential cardiac effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting and exercise conditions. Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound.

Timeline

Start
2015-05-04
Primary completion
2015-08-12
Completion
2015-08-13

Drugs

EvaluationDrugModalityDoseRoute
Subject OSORESNONTRINE Small molecule 50 mg Oral
Subject OSORESNONTRINE Small molecule 200 mg Oral

Indications

No indication recorded.