A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants

An Open-label, Fixed-sequence, Non-randomised, Drug-drug Interaction Study to Evaluate the Effect of Pantoprazole (Proton Pump Inhibitor) on the Pharmacokinetics of CHF10196 in Healthy Male Participants.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CHF10196; Drug: Pantoprazole

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chiesi Clinical trial Info; Phone Number: +390521279715; Email: clinicaltrials_info@chiesi.com

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Fortrea Clinical Research Unit (CRU) Limited
    • Contact: Firas Almezedi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• 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
• Normal vital signs
• Normal ECG
• Willingness to comply with contraception requirements

Key Exclusion Criteria:

• Recent participation in another clinical study
• Significant medical conditions
• Abnormal laboratory values
• Positive HIV or hepatitis tests
• Recent infection or COVID-19
• Drug or alcohol abuse
• Use of prohibited medications
• Gastrointestinal surgery affecting absorption
• Hypersensitivity to study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed Sequence Treatment; CHF10196 - Pantoprazole - Pantoprazole with CHF10196	Drug: CHF10196; Treatment Period 1: CHF10196 single dose administration on Day1; Treatment Period 2: CHF10196 single dose administration after pantoprazole single dose administration on Day13; Drug: Pantoprazole; Treatment Period 2: Pantoprazole single dose administration from Day8 to Day13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Benjamen Monaghan, Fortrea Clinical Research Unit (CRU)

Study record dates

Study Major Dates

• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pharmacokinetics; DDI; CHF10196; Dipeptidyl Peptidase 1 (DPP1) inhibitor
• Additional Relevant MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pantoprazole
• Other Study ID Numbers: CLI-10196AA1-05; 1014440 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No