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Healthy VolunteersPhase 1NCT07683793

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

A Phase 1 study testing CHF10196 and Pantoprazole in people with Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
CHF10196 and Pantoprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
14 Oct 2026to 9 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Use of prohibited medications
  • Gastrointestinal surgery affecting absorption
  • Hypersensitivity to study drugs

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chiesi Clinical trial Info contact

+390521279715

clinicaltrials_info@chiesi.com

United Kingdom1 site

  • Fortrea Clinical Research Unit (CRU) Limited

    Leeds

    Firas Almezedi

Other trials in United Kingdom

About this study

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.

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.

Being tested
CHF10196, Pantoprazole
Keywords
pharmacokinetics, CHF10196, DDI, Dipeptidyl Peptidase 1 (DPP1) inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07683793
Study groupRoleWhat they receive
Fixed Sequence TreatmentExperimentalCHF10196 - Pantoprazole - Pantoprazole with CHF10196
Receives: Drug: CHF10196; Drug: Pantoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: pre-dose up to 168 hours post-dose

  2. 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

    Measured: pre-dose up to 168 hours post-dose

  3. PK parameter: Cmax

    comparing the ratio of adjusted geometric means for maximum observed concentration when CHF10196 administered alone and when administered with pantoprazole

    Measured: pre-dose up to 168 hours post-dose

Secondary outcomes (12)

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

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

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

  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)

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

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

    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)

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

  4. 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)

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

  5. 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

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

  6. 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).

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

  7. 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

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

  8. 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)

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

  9. Additional pharmacokinetic parameters: CL/F

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

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

  10. Additional pharmacokinetic parameters: t1/2

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

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

  11. Additional pharmacokinetic parameters: Vd/F

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

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

  12. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start14 Oct 2026 (estimated)
  3. Primary completion9 Dec 2026 (estimated)
  4. Study completion9 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683793
Sponsor's protocol ID
CLI-10196AA1-05
Other IDs
1014440
Status last verified
Jul 2026
First submitted
26 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CHF10196 and Pantoprazole in people with Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chiesi Clinical trial Info (+390521279715, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK parameter: AUC0-∞ (time frame: pre-dose up to 168 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07683793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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