drugset / Trial / NCT01581684

Safety Tolerability and Pharmacokinetic of BI 411034

NCT01581684 ↗

Phase 1 Completed 62 enrolled Boehringer Ingelheim
RandomizedSingle-groupSingle-blindTreatment

Summary

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses. The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM). Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Timeline

Start
2012-04-01
Primary completion
2012-08-01
Completion
2012-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 411034 Unknown — Oral

Indications

No indication recorded.