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Clinical Trials in the UK / NCT07683793
Starting soon Phase 1

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 · tracked via the Priya Life Science UK tracker
Sponsor
Chiesi Farmaceutici S.p.A
Phase
Phase 1
Started
2026-10-14
Last updated
2026-07-06

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

CHF10196 →Pantoprazole →

CHF10196: Treatment Period 1: CHF10196 single dose administration on Day1; Treatment Period 2: CHF10196 single dose administration after pantoprazole single dose administration on Day13

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • PK parameter: AUC0-∞ — pre-dose up to 168 hours post-dose
    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
  • PK parameter: AUC0-t — pre-dose up to 168 hours post-dose
    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
  • PK parameter: Cmax — pre-dose up to 168 hours post-dose
    comparing the ratio of adjusted geometric means for maximum observed concentration when CHF10196 administered alone and when administered with pantoprazole

Trial sites (1)

FacilityCityRegionStatus
Fortrea Clinical Research Unit (CRU) Limited Leeds United Kingdom

On this site

📄 Protonix (pantoprazole) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07683793 on ClinicalTrials.gov ↗ ← All trials in the UK