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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
Sponsor: Chiesi Farmaceutici S.p.A.
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.
Official title: 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.
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-10-14
Completion Date
2026-12-09
Last Updated
2026-07-06
Healthy Volunteers
Yes
Conditions
Interventions
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
Locations (1)
Fortrea Clinical Research Unit (CRU) Limited
Leeds, United Kingdom