5 results
The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…
Primary Objective: Safety Run-in Period:To evaluate the occurrence of tumor lysis syndrome (TLS) and doselimiting toxicities (DLTs) with the concurrent administration of ibrutinib and venetoclax.Randomization Phase:To evaluate whether the…
We will examine the cognitive performance of healthy young participants at different time points after a single administration of biperiden. The behavioural outcomes and electrophysiological correlates will be linked with the serum levels of…
The main objectives of the trial are to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo.
- Characterization of the CNS PD profile of IV administered biperiden- Characterization of the pharmacokinetic profile of IV administered biperiden- To confirm the plasma concentration-effect relationship of biperiden using population PK-PD modeling…