drugset
drugset / Trial / NCT03971695

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

NCT03971695 ↗

Phase 1 Completed 73 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

Summary

The main objectives are: * Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses. * Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.

Timeline

Start
2019-06-18
Primary completion
2020-12-04
Completion
2020-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 706321 Unknown 0.3 mg Oral
Subject BI 706321 Unknown 0.6 mg Oral
Subject BI 706321 Unknown 1.2 mg Oral
Subject BI 706321 Unknown 2 mg Oral
Subject BI 706321 Unknown 4 mg Oral
Subject BI 706321 Unknown 8 mg Oral
Subject BI 706321 Unknown 15 mg Oral
Subject BI 706321 Unknown 25 mg Oral

Indications

No indication recorded.