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drugset / Trial / NCT03325712

This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam

NCT03325712 ↗

Phase 1 Completed 60 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this trial is to investigate safety and tolerability of BI 705564 in healthy male subjects, following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics, including dose proportionality and investigation of linearity.

Timeline

Start
2017-11-17
Primary completion
2018-11-26
Completion
2018-11-26

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 705564 Unknown 10 mg Oral
Subject BI 705564 Unknown 20 mg Oral
Subject BI 705564 Unknown 40 mg Oral
Subject BI 705564 Unknown 60 mg Oral
Subject BI 705564 Unknown 80 mg Oral
Subject Midazolam Small molecule — —

Indications

No indication recorded.