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NCT Number: NCT07683793

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit (CRU) Limited

Leeds, United Kingdom

Location contact

Firas Almezedi

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHF10196

Drug

Treatment Period 1:

CHF10196 single dose administration on Day1;

Treatment Period 2:

CHF10196 single dose administration after pantoprazole single dose administration on Day13

Pantoprazole

Drug

Treatment Period 2:

Pantoprazole single dose administration from Day8 to Day13

Primary outcomes

  1. PK parameter: AUC0-∞

    Time frame: 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

  2. PK parameter: AUC0-t

    Time frame: 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

  3. PK parameter: Cmax

    Time frame: 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

Secondary outcomes

  1. Safety and tolerability: Incidence of adverse events (AE)

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

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

  2. Safety and tolerability: Change from baselines for vital signs: PR

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

    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)

  3. Safety and tolerability: Change from baselines for vital signs - RR

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

    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)

  4. Safety and tolerability: Change from baselines for vital signs - blood pressure

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

    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)

  5. Safety and tolerability: Change from baselines for ECG

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

    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

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

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

    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).

  7. Safety and tolerability: Change from baseline for laboratory abnormalities

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

    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

  8. Additional pharmacokinetic parameters: AUC0-24h

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

    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)

  9. Additional pharmacokinetic parameters: CL/F

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

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

  10. Additional pharmacokinetic parameters: t1/2

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

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

  11. Additional pharmacokinetic parameters: Vd/F

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

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

  12. Additional pharmacokinetic parameters: tmax

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chiesi Clinical trial Info

CONTACT

[email protected]

+390521279715

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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