Trial results for a Phase 1 study of BI 3000202 in healthy men were posted on ClinicalTrials.gov on 2026-06-08. The study investigated the drug's safety, tolerability, and the influence of food on its pharmacokinetics. Key findings included a low incidence of drug-related adverse events, with 0 to 1 participant experiencing such events across various dose groups, and a geometric mean ratio for AUC0-24 (fed/fasted) of 85.25%.
Background
BI 3000202 is an investigational drug. This Phase 1 study aimed to understand its safety, tolerability, and how its concentration in the blood is affected by different doses and the presence of food, specifically assessing its relative bioavailability.
Trial design
The completed Phase 1 study (NCT05945888) enrolled 68 healthy men. The trial was designed in two parts: a single rising dose (SRD) part to assess safety, tolerability, and pharmacokinetics, and a food effect (FE) part to evaluate the influence of food on the relative bioavailability of BI 3000202. Interventions included various doses of BI 3000202 and a placebo matching BI 3000202.
Key results
The trial reported findings on drug-related adverse events and pharmacokinetic parameters.
- In the single rising dose (SRD) part, the number of any treatment-emergent adverse events assessed as drug-related by the investigator was 1 participant in the placebo matching BI 3000202 group. For the BI 3000202 dose groups, the numbers were 0 participants (Dose 1), 0 participants (Dose 2), 1 participant (Dose 3), 0 participants (Dose 4), 0 participants (Dose 5), 0 participants (Dose 6), and 0 participants (Dose 7).
For the food effect (FE) part, pharmacokinetic measurements included:
- The geometric least squares mean for Area Under the Concentration-time Curve (AUC0-24) was 901.43 Nanomoles times hour per Liter when BI 3000202 was administered fasted, compared to 768.45 Nanomoles times hour per Liter when administered fed.
- The geometric least squares mean for Maximum Measured Concentration (Cmax) was 229.43 Nanomoles per Liter when BI 3000202 was administered fasted, compared to 219.06 Nanomoles per Liter when administered fed.
Key analyses for the food effect part showed the following geometric mean ratios (fed/fasted) with 90% confidence intervals:
- For AUC0-24, one analysis showed a ratio of 85.25% (71.74% to 101.3%).
- For Cmax, the ratio was 95.48% (65.4% to 139.41%).
- Another analysis for AUC0-24 showed a ratio of 82.56% (70.27% to 97.01%).
What this means
The results from this Phase 1 study in healthy men indicate that BI 3000202 was generally well-tolerated across the tested doses, with a low number of drug-related adverse events reported. The pharmacokinetic data suggest that food intake influences the systemic exposure of BI 3000202, as evidenced by the reduction in AUC0-24 when administered with food. This food effect on bioavailability will be an important consideration for future development and potential dosing strategies of BI 3000202, particularly if consistent exposure is critical for its therapeutic effect. The Cmax also showed a slight reduction with food, though the confidence interval for the ratio was wider, indicating more variability. These initial findings are crucial for guiding further clinical investigation into higher phases of development.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05945888, titled "A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood", were posted on 2026-06-08 on clinicaltrials.gov.