The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.
Healthy male participants aged 18 to 55 years
Body mass index between 18.0 and 30.0 kg/m²
Non-smokers or ex-smokers (<5 pack-years)
Clinically healthy based on medical history and examination
Use of prohibited concomitant medications
Participation in another clinical study within 3 months
Clinically relevant medical conditions
Abnormal laboratory values
Sequential
Dabigatran Etexilate
DrugTreatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Rosuvastatin
DrugTreatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
CHF10196
DrugTreatment period 2: Single dose administered daily from Day 8 to Day 19
Pharmacokinetics of Dabigatran : AUC0-t
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided Confidential Intervals(CI), will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-t)
Pharmacokinetics of Dabigatran: AUC0-∞
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-∞)
Pharmacokinetics of Dabigatran: Cmax
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) maximum observed maximum observed concentration (Cmax)
Pharmacokinetics of Rosuvastatin :AUC0-t
The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin AUC0-t
Safety and Tolerability : Incidence of adverse events (AE)
Number and percentage of study participants by treatment with AEs, adverse events of special interest(AESIs),treatment emergent adverse event(TEAEs), adverse drug reaction(ADRs), non-serious TEAEs, serious TEAEs, serious ADRs, severe TEAEs, TEAEs leading to study discontinuation and to death
Safety and Tolerability : change from baseline for laboratory abnormalities
Clinical laboratory abnormalities, based on haematology and blood chemistry test results by treatment period (TP). Number of participants with abnormal blood laboratory test results. Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics
Safety and Tolerability: changes from baseline for vital signs - pulse rate
Mean changes from baseline to each post-dose timepoint in vital signs PR (pulse rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)
Safety and Tolerability: changes from baseline for vital signs - respiratory rate
Mean changes from baseline to each post-dose timepoint in vital signs RR (respiratory rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)
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