Trial results for nerandomilast (BI 1015550) in healthy Japanese men were posted on ClinicalTrials.gov on 2025-12-01. The Phase 1 study investigated the pharmacokinetics of nerandomilast, showing higher systemic exposure (AUC0-inf) and maximum concentration (Cmax) with an 18 mg dose compared to a 9 mg dose.
Background
Nerandomilast (BI 1015550) is an investigational drug. This study focused on understanding how the drug is absorbed, distributed, metabolized, and excreted in the body, specifically in a healthy Japanese male population.
Trial design
The study (NCT06139302) was a Phase 1 trial with an enrollment of 12 healthy Japanese male subjects. The trial's main objective was to investigate the pharmacokinetics of nerandomilast (BI 1015550) following oral administration of two different single doses: 9 mg and 18 mg.
Key results
The trial investigated the pharmacokinetics of nerandomilast at two different doses. Key measurements included the area under the concentration-time curve from 0 to infinity (AUC0-inf) and maximum measured concentration (Cmax) in plasma.
- For AUC0-inf at the nerandomilast 9 mg dose, the geometric mean was 2070 hours*nanomoles/Liter (h*nmol/L), with a geometric coefficient of variation of 13.8.
- For AUC0-inf at the nerandomilast 18 mg dose, the geometric mean was 3740 hours*nanomoles/Liter (h*nmol/L), with a geometric coefficient of variation of 52.8.
- For Cmax at the nerandomilast 9 mg dose, the geometric mean was 455 nanomoles/Liter (nmol/L), with a geometric coefficient of variation of 10.6.
- For Cmax at the nerandomilast 18 mg dose, the geometric mean was 628 nanomoles/Liter (nmol/L), with a geometric coefficient of variation of 138.
What this means
The results indicate that increasing the single oral dose of nerandomilast from 9 mg to 18 mg leads to higher systemic exposure and maximum plasma concentrations in healthy Japanese men. Specifically, the 18 mg dose resulted in a higher geometric mean for both AUC0-inf and Cmax compared to the 9 mg dose. These pharmacokinetic findings are essential for guiding dose selection and further clinical development of nerandomilast.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06139302, titled "A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men," were posted on 2025-12-01 on clinicaltrials.gov.