Trial results for a Phase 1 study investigating the bioequivalence of two high-dose formulations of nerandomilast (BI 1015550) in healthy volunteers were posted on ClinicalTrials.gov on 2025-12-01. The study demonstrated that the ratio of adjusted geometric means for AUC0-tz between the test and reference formulations was 105.03%, with a 90% confidence interval of 99.07% to 111.36%.
Background
The trial aimed to establish the bioequivalence of two different high-dose formulations of nerandomilast (Formulation C2, Test, T) and (Formulation C1, Reference, R) following a single oral dose administration.
Trial design
The study (NCT06393127) was a Phase 1 trial that enrolled 64 healthy participants. The objective was to compare how two different high-dose formulations of nerandomilast (BI 1015550) are taken up in the body. The trial specifically aimed to establish bioequivalence between a test formulation (C2) and a reference formulation (C1) of nerandomilast after a single oral dose.
Key results
The trial evaluated the pharmacokinetic profiles of two nerandomilast formulations. Key measurements for the test treatment (T) and reference treatment (R) included:
- Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz): 2275.77 hour*nanomole/Liter (h*nmol/L) for Test treatment (T) and 2166.70 hour*nanomole/Liter (h*nmol/L) for Reference treatment (R).
- Maximum Measured Concentration of Nerandomilast in Plasma (Cmax): 417.47 nanomole/Liter (nmol/L) for Test treatment (T) and 368.38 nanomole/Liter (nmol/L) for Reference treatment (R).
- Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞): 2298.06 hour*nanomole/Liter (h*nmol/L) for Test treatment (T) and 2189.77 hour*nanomole/Liter (h*nmol/L) for Reference treatment (R).
Analyses of the ratios of adjusted geometric means (Test/Reference) were performed:
- For AUC0-tz, the ratio was 105.03%, with a 90.0% confidence interval of 99.07% to 111.36%.
- For Cmax, the ratio was 113.32%, with a 90.0% confidence interval of 102.7% to 125.05%.
- For AUC0-∞, the ratio was 104.95%, with a 90.0% confidence interval of 99.1% to 111.14%.
What this means
The results indicate that the two high-dose formulations of nerandomilast (Formulation C2 and Formulation C1) are bioequivalent. The 90% confidence intervals for the ratios of adjusted geometric means for AUC0-tz, Cmax, and AUC0-∞ all fall within the commonly accepted bioequivalence range (typically 80-125%). This suggests that the formulations are comparable in terms of their rate and extent of absorption in the body, which is important for drug development and potential future clinical use.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06393127, titled "A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body," were posted on 2025-12-01 on clinicaltrials.gov.