drugset
drugset / Trial / NCT03315936

This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated

NCT03315936 ↗

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

Summary

This first-in man trial is designed to investigate the safety and tolerability of BI 894416 in healthy male subjects following oral administration of single rising doses. Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral solution.

Timeline

Start
2017-11-02
Primary completion
2018-09-10
Completion
2018-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 894416 Unknown 3 mg Oral
Subject BI 894416 Unknown 10 mg Oral
Subject BI 894416 Unknown 20 mg Oral
Subject BI 894416 Unknown 30 mg Oral
Subject BI 894416 Unknown 40 mg Oral
Subject BI 894416 Unknown 54 mg Oral
Subject BI 894416 Unknown 70 mg Oral

Indications

No indication recorded.