drugset / Trial / NCT03230487

This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body

NCT03230487

Phase 1 Completed 42 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

Summary

Part 1 (SRD (Single-rising dose)): The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing. Part 2 (MRD (Multiple-rising dose)): In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.

Timeline

Start
2017-08-10
Primary completion
2018-01-16
Completion
2018-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Nerandomilast Small molecule 6 mg Oral
Subject Nerandomilast Small molecule 12 mg Oral
Subject Nerandomilast Small molecule 36 mg Oral
Subject Nerandomilast Small molecule 48 mg Oral

Indications

No indication recorded.