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

Study Identifier:
CLI-10196AA1-05
ClinicalTrials.gov Identifier:
NCT07683793
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
+390521279715 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Healthy Volunteers
Study Drug
  • Drug: CHF10196
  • Drug: Pantoprazole
Date
Oct 2026 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
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
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
Healthy Volunteers
Yes

Protocol 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.

Study Locations

Location
Status
Location
Fortrea Clinical Research Unit (CRU) Limited
Leeds, United Kingdom
Status
N/A