drugset / Trial / NCT05380947

A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

NCT05380947

Phase 1 Completed 13 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.

Timeline

Start
2022-06-23
Primary completion
2022-09-13
Completion
2022-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabeprazole Small molecule
Subject Zongertinib Small molecule Oral

Indications

No indication recorded.