HealthyPhase 1NCT07141381

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

A Phase 1 study testing VRN110755 and Rabeprazole in people with Healthy, run by Voronoi, Inc at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: VRN110755 and Rabeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteAustralia
Study dates: 27 Aug 2025to 16 Apr 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
Use of CYP3A4 inhibitors/inducers or medications affecting metabolism of VRN110755 within 14 days prior to dosing.
Unwillingness to follow dietary restrictions (e.g., cannot consume high-fat meals).
Use of proton pump inhibitors, H2 blockers, or antacids within 8 weeks prior to first dose (except planned rabeprazole use in study).
Known hypersensitivity to PPIs (e.g., rabeprazole).
Planned or current participation in another investigational trial or use of another investigational product within 30 days or 5 half-lives.
Poor peripheral venous access.
Any condition that, in the opinion of the investigator, would jeopardize participant safety or interfere with study compliance or data integrity.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000

Other trials in Australia

About this study

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

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.

Read the detailed description

The study consists of two treatment sequences in a 3-period, crossover design. Approximately 24 healthy adult participants will be randomized 1:1 to one of the following sequences:

Sequence 1: Participants will receive VRN110755 80 mg orally in the fasted state (Period 1), then in the fed state (Period 2), and finally in the fed state with 5 days of rabeprazole pre-treatment (Period 3).

Sequence 2: Participants will receive VRN110755 80 mg orally in the fed state (Period 1), then in the fasted state (Period 2), and finally in the fasted state with 5 days of rabeprazole pre-treatment (Period 3).

Rabeprazole 20 mg will be administered orally once daily for 5 consecutive days prior to the final dosing of VRN110755 in Period 3.

All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood and urine samples will be collected at defined intervals for the analysis of VRN110755 and its metabolites.

Each participant's total study duration will be approximately 76 days, including screening, treatment, and follow-up.

Conditions: Healthy
Being tested: VRN110755, Rabeprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRN110755Drug
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.
RabeprazoleDrug
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.

Study groups in NCT07141381
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Rabeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

Incidence of Treatment-Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of single oral doses of VRN110755 administered under fasted, fed, and PPI conditions by assessing the incidence, severity, and relationship of TEAEs.
Measured: From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
Incidence of Serious Adverse Events (SAEs)
To monitor and document any SAEs occurring after VRN110755 administration under any treatment condition.
Measured: 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
The number of participants exhibiting abnormal laboratory values in hematology, biochemistry, coagulation, or urinalysis assessments..
Measured: 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
Change from baseline in ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcF (Fridericia). ECGs will be recorded after at least 5 minutes of rest in the supine position. Triplicate ECGs will be taken at screening; single ECGs will be performed at other scheduled timepoints unless clinically indicated.
Measured: 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
Change from baseline in systolic blood pressure measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Measured: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Diastolic Blood Pressure From Baseline
Change from baseline in diastolic blood pressure measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Measured: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Pulse Rate From Baseline
Change from baseline in pulse rate measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Measured: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Respiratory Rate From Baseline
Change from baseline in respiratory rate measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Measured: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Tympanic Temperature From Baseline
Change from baseline in tympanic temperature measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Measured: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Cumulative Amount Excreted (Ae) of VRN110755
Cumulative amount of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Measured: 0 to 24 hours post-dose in each study period.
Fraction Excreted (Fe) of VRN110755
Fraction of the administered dose of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Measured: 0 to 24 hours post-dose in each study period.
Renal Clearance (CLr) of VRN110755
Renal clearance of VRN110755, determined from urinary excretion and plasma concentration data under different study conditions.
Measured: 0 to 24 hours post-dose in each study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 202516 Apr 2026

First posted26 Aug 2025
Study start27 Aug 2025
Primary completion17 Dec 2025
Study completion16 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07141381
Sponsor's protocol ID: VRN110755-001
Status last verified: May 2026
First submitted: 24 Jul 2025
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07141381
Acronym / sponsor ID: VRN110755-001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Voronoi, IncIndustry (pharma, biotech, devices)
Study start: 27 Aug 2025 (actual)
Primary completion: 17 Dec 2025 (actual)
Study completion: 16 Apr 2026 (actual)
First posted: 26 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study consists of two treatment sequences in a 3-period, crossover design. Approximately 24 healthy adult participants will be randomized 1:1 to one of the following sequences:

Rabeprazole 20 mg will be administered orally once daily for 5 consecutive days prior to the final dosing of VRN110755 in Period 3.

Each participant's total study duration will be approximately 76 days, including screening, treatment, and follow-up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1: Fasted → Fed → Fed with PPI	Experimental	Drug: VRN110755Participants 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
Sequence 2: Fed → Fasted → Fasted with PPI	Experimental	Drug: RabeprazoleParticipants 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (22 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRN110755VRN110755 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	Sequence 1: Fasted → Fed → Fed with PPI
RabeprazoleRabeprazole 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.	Drug	Sequence 2: Fed → Fasted → Fasted with PPI

Primary outcome

Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC₀-inf) of VRN110755
Time frame: Up to 312 hours post-dose (for each treatment period)
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.
Maximum Observed Plasma Concentration (Cmax) of VRN110755
Time frame: Up to 312 hours post-dose (for each treatment period)
To assess the peak plasma concentration of VRN110755 under different dosing conditions (fasted, fed, fed/fasted + PPI).
Time to Maximum Observed Concentration (Tmax) of VRN110755
Time frame: Up to 312 hours post-dose (for each treatment period)
To assess the time to reach peak concentration of VRN110755 after single-dose oral administration under different conditions.
Comparison of Pharmacokinetic Parameters (AUC and Cmax Ratios) Across Treatment Conditions
Time frame: Up to 312 hours post-dose (for each treatment period)
To compare AUC and Cmax values of VRN110755 between fed vs. fasted, and PPI vs. non-PPI conditions using statistical analysis.

12 secondary outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
Incidence of Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Pulse Rate From Baseline
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Respiratory Rate From Baseline
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Change in Tympanic Temperature From Baseline
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Cumulative Amount Excreted (Ae) of VRN110755
Time frame: 0 to 24 hours post-dose in each study period.
Fraction Excreted (Fe) of VRN110755
Time frame: 0 to 24 hours post-dose in each study period.
Renal Clearance (CLr) of VRN110755
Time frame: 0 to 24 hours post-dose in each study period.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRN110755 and Rabeprazole in people with Healthy, run by Voronoi, Inc at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC₀-inf) of VRN110755 (time frame: Up to 312 hours post-dose (for each treatment period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07141381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.