drugset / Trial / NCT02068690

Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

NCT02068690

Phase 1 Completed 83 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Timeline

Start
2014-03-20
Primary completion
2014-09-10
Completion
2014-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Iclepertin Small molecule 0.5 mg Oral
Subject Iclepertin Small molecule 1 mg Oral
Subject Iclepertin Small molecule 2 mg Oral
Subject Iclepertin Small molecule 5 mg Oral
Subject Iclepertin Small molecule 10 mg Oral
Subject Iclepertin Small molecule 25 mg Oral
Subject Iclepertin Small molecule 50 mg Oral
Subject Iclepertin Small molecule 100 mg Oral
Subject Iclepertin Small molecule 150 mg Oral

Indications

No indication recorded.