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drugset / Trial / NCT03794323

A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood

NCT03794323 ↗

Phase 1 Completed 76 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses. The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Timeline

Start
2019-01-30
Primary completion
2019-08-12
Completion
2019-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 764122 Unknown 4 mg Oral
Subject BI 764122 Unknown 12 mg Oral
Subject BI 764122 Unknown 25 mg Oral
Subject BI 764122 Unknown 50 mg Oral
Subject BI 764122 Unknown 100 mg Oral
Subject BI 764122 Unknown 200 mg Oral
Subject BI 764122 Unknown 300 mg Oral
Subject BI 764122 Unknown 400 mg Oral

Indications

No indication recorded.