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Not yet recruiting 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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHF10196, Pantoprazole.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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.

Interventions

  • Drug CHF10196
    Treatment Period 1: CHF10196 single dose administration on Day1; Treatment Period 2: CHF10196 single dose administration after pantoprazole single dose administration on Day13
  • Drug Pantoprazole
    Treatment Period 2: Pantoprazole single dose administration from Day8 to Day13

Primary outcome measures

  • PK parameter: AUC0-∞ [Time frame: pre-dose up to 168 hours post-dose]
  • PK parameter: AUC0-t [Time frame: pre-dose up to 168 hours post-dose]
  • PK parameter: Cmax [Time frame: pre-dose up to 168 hours post-dose]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Fortrea Clinical Research Unit (CRU) Limited — Leeds

Identifiers

NCT: NCT07683793 · CLI-10196AA1-05 · 1014440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗