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
NCT07683793 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-07-06
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.
Conditions
- Healthy Volunteers
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
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Benjamen Monaghan · Fortrea Clinical Research Unit (CRU)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-10-14
- Primary Completion
- 2026-12-09
- Completion
- 2026-12-09
Countries
- United Kingdom
Study Locations
More Related Trials
-
Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination
NCT02684799 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole
NCT04139226 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole
NCT07262736 ·Status: COMPLETED ·Phase: PHASE1
-
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
NCT01918176 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
NCT02957474 ·Status: COMPLETED ·Phase: PHASE1
-
SSP-002358 Drug Interaction Study With Omeprazole
NCT01415349 ·Status: COMPLETED ·Phase: PHASE1
-
Rapid Screening Phenotype Test To Evaluate CYP 2C19 Enzyme Activity Using Stable Isotope [13C]Pantoprazole
NCT00668902 ·Status: COMPLETED ·Phase: NA
-
Effect of a Proton Pump Inhibitor on the PK of Tepotinib
NCT03531762 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Explore the Effect of Acid-reducing Agents
NCT04935112 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1
NCT03011463 ·Status: COMPLETED ·Phase: PHASE1
-
Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
NCT01882296 ·Status: UNKNOWN ·Phase: PHASE1
-
Study Evaluating Pantoprazole in Adolescents With GERD
NCT00367614 ·Status: COMPLETED ·Phase: PHASE3
-
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
NCT00915239 ·Status: COMPLETED ·Phase: NA
-
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
NCT00383916 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin
NCT01146483 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003)
NCT06619314 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
NCT05497557 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
NCT02365558 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
NCT01179659 ·Status: COMPLETED ·Phase: PHASE1
-
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
NCT02623816 ·Status: COMPLETED ·Phase: PHASE4
-
Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions
NCT00835393 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
NCT06054464 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
NCT02922933 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat
NCT07171619 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)
NCT01470690 ·Status: COMPLETED ·Phase: PHASE1