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

ConditionHealthy Volunteers

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age18-55

SponsorChiesi Farmaceutici S.p.A.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Recent participation in another clinical study

Significant medical conditions

Abnormal laboratory values

Positive HIV or hepatitis tests

Trial design

Treatments tested in this trial

CHF10196
Pantoprazole

Treatment groups

18 Participants

are divided into 1 treatment group

Sponsors and collaborators

Chiesi Farmaceutici S.p.A.

Lead sponsor

Source ClinicalTrials.gov