A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
NCT07141381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-05-08
Summary
This is a Phase 1, open-label, randomized, single-center study to evaluate the effect of food and a proton pump inhibitor (PPI) on the pharmacokinetics (PK) of VRN110755 in healthy adult participants. The primary aim of this study is to assess the impact of food and rabeprazole co-administration on the systemic exposure of VRN110755. Safety and tolerability will also be evaluated.
Conditions
- Healthy
Interventions
- DRUG
-
VRN110755
VRN110755 is an investigational EGFR inhibitor administered as an 80 mg oral capsule. It will be given to all participants under fasted, fed, and PPI pre-treated conditions across three periods in a crossover design.
- DRUG
-
Rabeprazole
Rabeprazole 20 mg will be administered orally once daily for 5 days prior to VRN110755 dosing in Period 3. This is to assess the effect of increased gastric pH (via proton pump inhibition) on the pharmacokinetics of VRN110755.
Sponsors & Collaborators
-
Voronoi, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-27
- Primary Completion
- 2025-12-17
- Completion
- 2026-04-16
Countries
- Australia
Study Locations
More Related Trials
-
A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
NCT02475161 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
NCT03789032 ·Status: COMPLETED ·Phase: PHASE1
-
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
NCT01287091 ·Status: COMPLETED ·Phase: PHASE1
-
A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers
NCT04157881 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults.
NCT06105983 ·Status: COMPLETED ·Phase: PHASE1
-
A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
NCT05923411 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
NCT05630677 ·Status: COMPLETED ·Phase: PHASE1
-
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
NCT00539240 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Fruquintinib Food Effect and Proton Pump Inhibitor Study
NCT04645940 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
NCT04211545 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
NCT01241409 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Monitor Intragastric pH in Patients Taking Rabeprazole vs. Patients Taking Pantoprazole
NCT00378287 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
NCT01277718 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
NCT01397084 ·Status: COMPLETED ·Phase: PHASE4
-
HMPL-523 Food Effect and Proton Pump Inhibitor Study
NCT05571787 ·Status: COMPLETED ·Phase: PHASE1
-
Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
NCT01821521 ·Status: UNKNOWN ·Phase: PHASE1
-
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
NCT03220191 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.
NCT03137134 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat
NCT07171619 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881
NCT04128787 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn
NCT00237367 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
NCT00999128 ·Status: COMPLETED ·Phase: PHASE1
-
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
NCT00251732 ·Status: COMPLETED ·Phase: PHASE4
-
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
NCT01101646 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
NCT03464058 ·Status: COMPLETED ·Phase: PHASE1