This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants. Participants receive CHF10196 alone and in combination with pantoprazole to assess potential drug-drug interaction (DDI) effects on systemic exposure.
BMI (body mass index) between 18.0 and 30.0 kg/m²
Weight between 45 and 100 kg
Non-smokers or ex-smokers (<5 pack-years)
Clinically healthy based on medical history and examination
Recent participation in another clinical study
Significant medical conditions
Abnormal laboratory values
Positive HIV or hepatitis tests
Sequential
CHF10196
DrugTreatment Period 1: CHF10196 single dose administration on Day1; Treatment Period 2: CHF10196 single dose administration after pantoprazole single dose administration on Day13
Pantoprazole
DrugTreatment Period 2: Pantoprazole single dose administration from Day8 to Day13
PK parameter: AUC0-∞
comparing the ratio of adjusted geometric means for area under the concentration time curve from time 0 extrapolated to infinity (AUC0-∞) when CHF10196 administered alone and when administered with pantoprazole
PK parameter: AUC0-t
comparing the ratio of adjusted geometric means for area under the plasma concentration time curve from time 0 to last quantifiable concentration (AUC0-t) when CHF10196 administered alone and when administered with pantoprazole
PK parameter: Cmax
comparing the ratio of adjusted geometric means for maximum observed concentration when CHF10196 administered alone and when administered with pantoprazole
Safety and tolerability: Incidence of adverse events (AE)
Number and percentage of adverse events (AE) when CHF10196 administered alone and when administered with pantoprazole
Safety and tolerability: Change from baselines for vital signs: PR
Mean changes from baselines to each post-dose timepoint in PR (pulse rate), by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)
Safety and tolerability: Change from baselines for vital signs - RR
Mean changes from baselines to each post-dose timepoint in vital signs: RR (respiratory rate) by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)
Safety and tolerability: Change from baselines for vital signs - blood pressure
Mean changes from baselines to each post-dose timepoint in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
