drugset / Trial / NCT01971502

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469

NCT01971502

Phase 1 Completed 68 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.

Timeline

Start
2013-10
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 1060469 Unknown Oral

Indications

No indication recorded.