A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755

NCT07141381 | Recruiting Phase 1

• 1 other identifier: VRN110755-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC₀-inf) of VRN110755

  To evaluate the effect of food and rabeprazole on the extent of systemic exposure of VRN110755 by measuring AUC₀-inf under fasted, fed, and PPI conditions.

  Up to 312 hours post-dose (for each treatment period)

• Maximum Observed Plasma Concentration (Cmax) of VRN110755

  To assess the peak plasma concentration of VRN110755 under different dosing conditions (fasted, fed, fed/fasted + PPI).

  Up to 312 hours post-dose (for each treatment period)

• Time to Maximum Observed Concentration (Tmax) of VRN110755

  To assess the time to reach peak concentration of VRN110755 after single-dose oral administration under different conditions.

  Up to 312 hours post-dose (for each treatment period)

• Comparison of Pharmacokinetic Parameters (AUC and Cmax Ratios) Across Treatment Conditions

  To compare AUC and Cmax values of VRN110755 between fed vs. fasted, and PPI vs. non-PPI conditions using statistical analysis.

  Up to 312 hours post-dose (for each treatment period)

Secondary Outcomes (12)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)

• Incidence of Serious Adverse Events (SAEs)

  From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)

• Number of Participants with Abnormal Clinical Laboratory Test Results

  Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)

• Change in 12-lead ECG Parameters From Baseline

  Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)

• Change in Systolic Blood Pressure From Baseline

  Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).

Study Arms (2)

Sequence 1: Fasted → Fed → Fed with PPI

EXPERIMENTAL

Participants in this sequence will receive VRN110755 80 mg orally under the following conditions across three periods: Period 1: Fasted state Period 2: Fed state (standard high-fat meal) Period 3: Fed state after 5 days of rabeprazole 20 mg daily

Drug: VRN110755

Sequence 2: Fed → Fasted → Fasted with PPI

EXPERIMENTAL

Participants in this sequence will receive VRN110755 80 mg orally under the following conditions across three periods: Period 1: Fed state (standard high-fat meal) Period 2: Fasted state Period 3: Fasted state after 5 days of rabeprazole 20 mg daily

Drug: Rabeprazole

Interventions

VRN110755 DRUG

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.

Sequence 1: Fasted → Fed → Fed with PPI

Rabeprazole DRUG

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.

Sequence 2: Fed → Fasted → Fasted with PPI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged between 18 and 65 years, inclusive, at the time of informed consent.
• In good general health, with no significant medical history and no clinically significant abnormalities on physical examination, as determined by the investigator.
• Body mass index (BMI) between 18.0 and 32.0 kg/m², and weight ≥ 50 kg at screening.
• Clinical laboratory values within normal ranges, unless deemed not clinically significant by the investigator.
• Female participants of childbearing potential who are sexually active with a male partner must agree to use highly effective contraception methods from screening through 6 months after the last dose of investigational product.
• Female participants must have a negative pregnancy test at screening and pre-dose.
• Women not of childbearing potential must be surgically sterile or postmenopausal for ≥12 months.
• Male participants must agree to use barrier contraception in conjunction with a highly effective method if engaging with women of childbearing potential, from screening through 6 months after the last dose.
• Male participants must not donate sperm, and female participants must not donate ova, from the first dose through 6 months after the last dose.
• Able and willing to comply with study procedures and site visits.
• Able and willing to provide written informed consent before any study procedures are performed.

You may not qualify if:

• Any significant medical or psychiatric condition that may interfere with study participation or interpretation of results, as determined by the investigator.
• Clinically significant abnormal ECG findings, including QTcF \> 450 ms (males) or \> 470 ms (females).
• Abnormal vital signs at screening (e.g., systolic BP \> 140 or \< 90 mmHg, diastolic BP \> 90 or \< 60 mmHg, or history of symptomatic hypotension).
• Active liver disease, or AST/ALT \> 1.5 × upper limit of normal.
• Known or suspected gastrointestinal disorders that may interfere with drug absorption (e.g., IBD, chronic diarrhea, malabsorption).
• Positive urine drug screen or alcohol breath test at screening.
• Regular alcohol use \>14 standard drinks/week or \>3 drinks/day.
• Positive test for HIV, Hepatitis B (HBsAg), or Hepatitis C antibody.
• History of severe allergies or anaphylaxis, or known hypersensitivity to study drug components.
• Recent infections requiring parenteral antibiotics within 6 months before first dose.
• Vaccination with live vaccine within 4 weeks prior to first dose.
• Blood donation \>400 mL within 60 days, or component donation within 30 days prior to dosing.
• eGFR ≤ 90 mL/min/1.73 m² at screening.
• Use of nicotine-containing products within 7 days before dosing or unwillingness to abstain during the study.
• Use of prescription/OTC medications, herbal products, or supplements within 14 days prior to dosing, unless approved by the investigator.

Sponsors & Collaborators

• Voronoi, Inc: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Rutu Dabhi

CONTACT

+1 201-515-9340; dabhirutu@voronoi.io

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 26, 2025
• Study Start: August 27, 2025
• Primary Completion: December 17, 2025
• Study Completion: January 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)