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RECRUITING
NCT07141381
PHASE1

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

Sponsor: Voronoi, Inc

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-label, 3-Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-27

Completion Date

2026-01-30

Last Updated

2025-09-23

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, Australia