Trial results for a Phase 1 study (NCT06624072) investigating two formulations of nerandomilast tablets in healthy individuals were posted on ClinicalTrials.gov on 2026-01-08. The study found that the pediatric formulation of nerandomilast showed a reduction in maximum plasma concentration (Cmax) of approximately 31% when taken with food compared to a fasted state.
Background
The main objective of this trial was to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.
Trial design
The study (NCT06624072) was a Phase 1 trial that enrolled 15 healthy participants. The trial compared the pharmacokinetics of an 18 mg adult formulation of nerandomilast and an 18 mg pediatric formulation, assessing the impact of food on the pediatric formulation. Participants were evaluated in fasted and fed states for the pediatric formulation, and in a fasted state for the adult formulation.
Key results
The pharmacokinetic analysis compared the pediatric formulation (Treatment T1) to the adult formulation (Reference R) in a fasted state, and the pediatric formulation in a fed state (Treatment T2) to the pediatric formulation in a fasted state (Treatment T1).
- Comparison of Pediatric (Fasted) vs. Adult (Fasted):
- The ratio of adjusted geometric means for AUC0-tz (Area Under the Concentration-time Curve from 0 to the Last Quantifiable Data Point) was 103.23% (90.0% CI: 97.31 to 109.52).
- The ratio for Cmax (Maximum Measured Concentration) was 104.34% (90.0% CI: 91.0 to 119.65).
- The ratio for AUC0-∞ (Area Under the Concentration-time Curve from 0 extrapolated to infinity) was 103.06% (90.0% CI: 97.22 to 109.25).
- Comparison of Pediatric (Fed) vs. Pediatric (Fasted):
- The ratio of adjusted geometric means for AUC0-tz was 95.56% (90.0% CI: 89.37 to 102.18).
- The ratio for Cmax was 68.71% (90.0% CI: 61.23 to 77.11).
- The ratio for AUC0-∞ was 95.73% (90.0% CI: 89.47 to 102.42).
What this means
The pharmacokinetic data suggest that the overall exposure (AUC) of the nerandomilast pediatric formulation is largely comparable to the adult formulation in a fasted state, and also similar between fasted and fed conditions for the pediatric formulation. The ratios for AUC were generally close to 100%. However, a significant food effect was observed for Cmax, with the pediatric formulation demonstrating an approximate 31% reduction in maximum plasma concentration when taken with food. This indicates that food intake substantially impacts the rate of absorption, which is an important consideration for dosing recommendations and maintaining consistent drug levels, especially in pediatric patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06624072, titled "A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food," were posted on 2026-01-08 on clinicaltrials.gov.