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

NCT07683793 | Not Yet Recruiting Phase 1

• 2 other identifiers: CLI-10196AA1-051014440
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

pharmacokinetics; CHF10196; DDI; Dipeptidyl Peptidase 1 (DPP1) inhibitor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Safety and tolerability: Incidence of adverse events (AE)

  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

  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

  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

  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

  Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2

Study Arms (1)

Fixed Sequence Treatment

EXPERIMENTAL

CHF10196 - Pantoprazole - Pantoprazole with CHF10196

Drug: CHF10196; Drug: Pantoprazole

Interventions

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

Fixed Sequence Treatment

Pantoprazole DRUG

Treatment Period 2: Pantoprazole single dose administration from Day8 to Day13

Fixed Sequence Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Fortrea Clinical Research Unit (CRU) Limited

Leeds, United Kingdom

Location

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Benjamen Monaghan

  Fortrea Clinical Research Unit (CRU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiesi Clinical trial Info

CONTACT

+390521279715; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)