Fortrea Clinical Research Unit (CRU) Limited
Leeds, United Kingdom
Location contact
Firas Almezedi
CONTACT
NCT Number: NCT07683793
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.
Trial opening soon.
Get Notified18 year–55 year
Male
Interventional
Phase 1
Leeds, United Kingdom
Firas Almezedi
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Treatment Period 1:
CHF10196 single dose administration on Day1;
Treatment Period 2:
CHF10196 single dose administration after pantoprazole single dose administration on Day13
Treatment Period 2:
Pantoprazole single dose administration from Day8 to Day13
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
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
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
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
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)
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)
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)
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
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).
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
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)
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
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
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
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)
Contact information is provided by the study sponsor or research team.
Chiesi Farmaceutici S.p.A.
Industry
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.
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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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