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| ID | Type | Description | Link |
|---|---|---|---|
| 1014440 | Other Identifier | IRAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Sequence Treatment | Experimental | CHF10196 - Pantoprazole - Pantoprazole with CHF10196 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF10196 | Drug | Treatment Period 1: CHF10196 single dose administration on Day1; Treatment Period 2: CHF10196 single dose administration after pantoprazole single dose administration on Day13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre-dose up to 168 hours post-dose |
| 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 | pre-dose up to 168 hours post-dose |
| PK parameter: Cmax | comparing the ratio of adjusted geometric means for maximum observed concentration when CHF10196 administered alone and when administered with pantoprazole | pre-dose up to 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Incidence of adverse events (AE) | Number and percentage of adverse events (AE) when CHF10196 administered alone and when administered with pantoprazole | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| Safety and tolerability: Change from baselines for vital signs: PR |
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Key Inclusion Criteria:
Key Exclusion Criteria:
The investigational medicinal product (IMP) is a CYP3A substrate. Highly effective contraceptives, particularly oral contraceptives, interact with CYP3A and could confound PK results. Including women would therefore introduce variables incompatible with the study's objective. Additionally, dosing women not using effective contraception would be ethically inappropriate. Male-only DDI studies are a common and accepted approach in such contexts
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiesi Clinical trial Info | Contact | +390521279715 | clinicaltrials_info@chiesi.com |
| Name | Affiliation | Role |
|---|---|---|
| Benjamen Monaghan | Fortrea Clinical Research Unit (CRU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit (CRU) Limited | Leeds | United Kingdom |
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website
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| Pantoprazole | Drug | Treatment Period 2: Pantoprazole single dose administration from Day8 to Day13 |
|
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) |
| Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2 |
| 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) | Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2 |
| 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) | Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2 |
| Safety and tolerability: Change from baselines for ECG | change from baselines in milliseconds (ms). Intervals recorded: PR , RR, QT, QTc, QRS duration, QTcF (Fridericia-corrected QT interval Baselines (the last value before the first administration of any CHF10196 of each treatment period (TP) or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196 | Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2 |
| Safety and tolerability: Change from baseline for ECG (HR) | change from baseline for ECG recording of heart rate (HR) Baselines (the last value before the first administration of any CHF10196 of each Treatment Period (TP) or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196). | Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2 |
| Safety and tolerability: Change from baseline for laboratory abnormalities | 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 | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| Additional pharmacokinetic parameters: AUC0-24h | comparing the ratio of adjusted geometric means for the area under the plasma concentration time curve from time 0 to 24 h post-dose when CHF10196 administered alone and when administered with pantoprazole (with their 90% two-sided Confidence Intervals) | From Day 1 to Day 2 for treatment period 1; from Day 13 to Day 14 for treatment period 2 |
| Additional pharmacokinetic parameters: CL/F | comparing the total body clearance (CL/F) by treatment period using descriptive statistics | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| Additional pharmacokinetic parameters: t1/2 | comparing the terminal half-life (t1/2) by treatment period using descriptive statistics | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| Additional pharmacokinetic parameters: Vd/F | comparing the apparent volume of distribution (Vd/F) by treatment period using descriptive statistics | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| Additional pharmacokinetic parameters: tmax | Evaluating the Hodges-Lehmann non-parametric estimate of location shift between CHF10196 with pantoprazole (test) and CHF10196 alone (reference) in median time corresponding to maximum plasma when CHF10196 administered alone and when administered with pantoprazole concentration (tmax) | From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2 |
| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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