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

Phase 1Not Yet RecruitingNCT07683793

Chiesi Farmaceutici S.p.A.18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

CHF10196DRUG

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

PantoprazoleDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit (CRU) Limited

Leeds, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: pre-dose up to 168 hours post-dose

Secondary Outcomes

Safety and tolerability: Incidence of adverse events (AE)

Number and percentage of adverse events (AE) when CHF10196 administered alone and when administered with pantoprazole

Time frame: 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

Mean changes from baselines to each post-dose timepoint in PR (pulse rate), by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)

Time frame: 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

Central Contacts

Chiesi Clinical trial Info

CONTACT

+390521279715 clinicaltrials_info@chiesi.com

Data from ClinicalTrials.gov

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Mean changes from baselines to each post-dose timepoint in vital signs: RR (respiratory rate) by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)

Time frame: 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

Mean changes from baselines to each post-dose timepoint in vital signs (Systolic Blood Pressure and Diastolic Blood Pressure) by treatment period (TP). Baselines (the last value before the first administration of any CHF10196 of each TP or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196)

Time frame: 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

change from baselines in milliseconds (ms). Intervals recorded: PR , RR, QT, QTc, QRS duration, QTcF (Fridericia-corrected QT interval Baselines (the last value before the first administration of any CHF10196 of each treatment period (TP) or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196

Time frame: Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2

Safety and tolerability: Change from baseline for ECG (HR)

change from baseline for ECG recording of heart rate (HR) Baselines (the last value before the first administration of any CHF10196 of each Treatment Period (TP) or pantoprazole (TP2 only). In TP2, two separate baselines will be derived relative to pantoprazole and CHF10196).

Time frame: Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2

Safety and tolerability: Change from baseline for laboratory abnormalities

Number of participants with abnormal blood laboratory test results. Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics

Time frame: From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2

Additional pharmacokinetic parameters: AUC0-24h

comparing the ratio of adjusted geometric means for the area under the plasma concentration time curve from time 0 to 24 h post-dose when CHF10196 administered alone and when administered with pantoprazole (with their 90% two-sided Confidence Intervals)

Time frame: From Day 1 to Day 2 for treatment period 1; from Day 13 to Day 14 for treatment period 2

Additional pharmacokinetic parameters: CL/F

comparing the total body clearance (CL/F) by treatment period using descriptive statistics

Time frame: From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2

Additional pharmacokinetic parameters: t1/2

comparing the terminal half-life (t1/2) by treatment period using descriptive statistics

Time frame: From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2

Additional pharmacokinetic parameters: Vd/F

comparing the apparent volume of distribution (Vd/F) by treatment period using descriptive statistics

Time frame: From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2

Additional pharmacokinetic parameters: tmax

Evaluating the Hodges-Lehmann non-parametric estimate of location shift between CHF10196 with pantoprazole (test) and CHF10196 alone (reference) in median time corresponding to maximum plasma when CHF10196 administered alone and when administered with pantoprazole concentration (tmax)

Time frame: From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2