A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol

Experimentell: Fixed-Sequence treatment

All participants will receive dabigatran alone and rosuvastatin alone in Treatment Period 1. During Treatment Period 2, participants will receive CHF10196 alone, with dabigatran, and with rosuvastatin.

Läkemedel: Dabigatran Etexilate

Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13

Läkemedel: Rosuvastatin

Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16

Läkemedel: CHF10196

Treatment 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

Pharmacokinetics of Rosuvastatin : AUC0-∞

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-∞)

Pharmacokinetics of Rosuvastatin: Cmax

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 Cmax

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)

Safety and Tolerability: changes from baseline for vital signs - blood pressure

Mean changes from baseline to each post-dose timepoint in vital signs systolic blood pressure (SBP) and diastolic blood pressure (DBP) 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 : change from baseline for ECG intervals

Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG parameters. Intervals recorded: RR, PR, QT, QTc (Corrected QT interval), and QTcF (Fridericia corrected QT interval), and QRS duration 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 : change from baseline for ECG HR

Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG recording of Heart Rate (HR). 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)

Additional Pharmacokinetic Parameters : CL/F of dabigatran

total body clearance (CL/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP

Additional Pharmacokinetic Parameters: CL/F of resuvastatin

total body clearance (CL/F) of rosuvastatin will be analysed with descriptive statistics by TP

Additional Pharmacokinetic Parameters: Vd/F of dabigatran

Apparent volume of distribution (Vd/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP

Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin

Apparent volume of distribution (Vd/F) of rosuvastatin will be analysed with descriptive statistics by TP

Additional Pharmacokinetic Parameters: tmax of dabigatran

Difference in median plasma tmax of dabigatran (free and total) between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone) with 90% two-sided CIs

Additional Pharmacokinetic Parameters: tmax of rosuvastatin

Difference in median plasma tmax of rosuvastatin between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone) with 90% two-sided CIs