drugset
drugset / Trial / NCT03004404

To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers

NCT03004404 ↗

Phase 1 Completed 84 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of single rising doses after fasting and/or non-fasting conditions. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730357 after single dosing. The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative bioavailability of tablet fasted versus oral solution fasted and the influence of food on the bioavailability of tablet fasted versus tablet fed.

Timeline

Start
2017-01-12
Primary completion
2017-08-15
Completion
2017-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 730357 Unknown 2 mg Oral
Subject BI 730357 Unknown 8 mg Oral
Subject BI 730357 Unknown 25 mg Oral
Subject BI 730357 Unknown 50 mg Oral
Subject BI 730357 Unknown 100 mg Oral
Subject BI 730357 Unknown 200 mg Oral
Subject BI 730357 Unknown 400 mg Oral
Subject BI 730357 Unknown 800 mg Oral

Indications

No indication recorded.