Will your breakfast ruin this cancer pill? new trial investigates
NCT ID NCT07550946
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-stage trial in 24 healthy adults examines how food and a common stomach-acid reducer (a proton pump inhibitor) change the way the body absorbs a new drug called VRN101099, which is being developed for solid tumors. Researchers will measure drug levels in the blood and urine under different conditions to find the best way to take it. The goal is to guide future dosing instructions for cancer patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VRN101099
- What this could lead to
- If successful, this study will help determine the best way to take VRN101099 with or without food or acid reducers, potentially improving future cancer treatments.
- What could go wrong
- This is an early phase 1 trial in only 24 healthy people, not patients. Results may not predict effects in cancer patients or guarantee safety or effectiveness.
Why investors are watching
Voronoi, Inc. is running a phase 1 trial in 24 healthy adults to see how food and a common stomach-acid drug change the absorption of its cancer drug VRN101099. For a micro-cap company with few assets, this readout matters because it will guide how future patients take the drug, and it is one of the few public data points investors can track.
If it works: A positive result showing the drug is safe and well tolerated, with clear guidance on food and acid-reducer effects, could support the company's plans for treating solid tumors and cancers. It may also strengthen confidence in the drug's development path.
If it fails: The trial could show that food or the acid reducer changes absorption in a way that complicates dosing, or the drug could cause safety issues. Phase 1 trials in healthy people often fail or get delayed, and any setback could hurt a company of this size.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female aged between 18 and 65 years of age (inclusive at the time of informed consent). 2. In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP (at the discretion of the PI or designee). 3. BMI between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at Screening. 4. Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator. 5. Female participants must be either not of childbearing potential or if they are a woman of childbearing potential and are engaged in heterosexual intercourse, they must agree to use an acceptable, highly effective contraception method in conjunction with a condom for the male partner from Screening until 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP). 6. Male participants must not be of childbearing potential, or if they are engaged in sexual relations with WOCBP, they must agree to use a condom in conjunction with an acceptable, highly effective contraception method for the female partner from Screening until 100 days after the last dose of the IP. 7. Males must not donate sperm and females must not donate ova from the first dose of IP until at least 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP). 8. Able and willing to attend the necessary visits to the CRU. 9. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures. Exclusion Criteria: 1. Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. This includes but may not be limited to: medical histories (eg, hepatic/biliary, renal, cardiovascular, endocrine, respiratory, digestive, haematologic, oncologic \[except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to the first administration of IP\], central nervous system, psychiatric, musculoskeletal) or past medical/surgical histories that may affect drug absorption, distribution, metabolism, or excretion (excluding simple appendectomy or herniorrhaphy). 2. Participants with known or suspected conditions or significant gastrointestinal disorders that may interfere with drug absorption (eg, inflammatory bowel disease, chronic diarhoea, malabsorption syndromes, or prior gastrointestinal surgery affecting absorption). 3. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents. 4. History of hypersensitivity and/or intolerance to PPIs. 5. History of infections requiring parenteral antibiotics within 6 months prior to the first administration of IP. 6. Blood donations of ≥ 400 mL or significant blood loss within 60 days prior to the first administration of investigational product (IP), plasma donation within 7 days prior to the first administration of IP, or platelet donation within 30 days prior to the first administration of IP. Participants must also agree not to donate blood, plasma, or platelets during the study and for at least 30 days after the last dose of IP. 7. Abnormal findings on 12-lead (triplicate) ECG at Screening that are considered by the PI or designee to be clinically significant; or has a QTcF (Fridericia's formula) interval at Screening of \> 450 msec for males or \> 470 msec for females based on the average of the 3 readings. Repeat testing at Screening is acceptable for abnormal values at the discretion of the Investigator (once per parameter). 8. Abnormal vital sign findings at Screening that are considered clinically significant by the Principal Investigator (PI) or designee, including systolic blood pressure \>140 mmHg or \< 90 mmHg, diastolic blood pressure \> 90 mmHg or \< 50 mmHg, or a history of symptomatic hypotension. If a screening value falls outside these limits, repeat measurement is permitted at the discretion of the Investigator, with one repeat assessment allowed per parameter. Eligibility should be based on the repeat value. 9. Active liver disease, or AST and/or ALT \> 1.5 × upper limit of normal at Screening. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator. 10. Estimated glomerular filtration rate (eGFR) of ≤ 80 mL/min/ 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula. 11. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening. 12. Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device), within 14 days prior to the first administration of the IP; or use of any over the counter medication, herbal remedies, supplements, or vitamins within 7 days prior to the first administration of IP and during course of study. Note: Simple analgesia (eg, paracetamol) may be permitted at the discretion of the PI, provided they are used within the recommended maximum daily doses as specified in the package insert. 13. Use of any drugs, herbal supplements, or foods that are known to be strong or moderate inhibitors/inducers of CYP3A4 (eg, carbamazepine, rifampin, St. John's wort, ketoconazole, ginkgo biloba, grapefruit, grapefruit juice) from within 30 days prior to the first administration of IP until the end of the study. 14. Use of PPIs, histamine (H)2 blockers, potassium-competitive acid blockers, or locally-acting antacids within 8 weeks before the first dose of IP, or requiring these medications during the study (except for the planned use of rabeprazole specified in the protocol) 15. Vaccination with a live vaccine within 4 weeks prior to the first administration of IP (and up until 14 days after the last dose of the IP). 16. Use of any IP or investigational medical device within 30 days prior to the first administration of IP, or 5 half lives of the product (whichever is the longest), and during the course of the study. 17. Positive toxicology screening panel (urine test including qualitative identification of amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, and tricyclic antidepressants), or alcohol breath test at Screening. Note: A single repeat test in the event of a false positive is permitted for the drug of abuse urine test at the discretion of the Investigator. 18. History of regular alcohol consumption defined as \> 14 standard drinks per week or \> 3 standard drinks on any single day (where 1 standard drink = 10 g of alcohol) within 3 months prior to Screening. 19. Unwilling or unable to abstain from the consumption of alcohol and caffeine containing food or drinks beginning 72 hours prior to the first administration of IP and until the end of the study. 20. Unwilling to abstain from cigarettes or nicotine-containing products (eg, cigars, vapes, nicotine patches) for at least 7 days prior to first IP administration through to the end of the study, or is considered to be dependent on nicotine at the discretion of the PI. Note: Participants that are considered light or social smokers (defined as ≤ 5 cigarettes per week) will be considered eligible for entry into the study but must also adhere to these restrictions. 21. Unwilling to refrain from strenuous exercise (including weightlifting) from 48 hours prior to each admission (on Day -1, Day 11, and Day 28), during the inpatient stays, and for 48 hours prior to any outpatient visit (including the EOS visit). 22. Unable or unwilling to consume a high-fat meal. 23. Pregnant or lactating. 24. Poor peripheral venous access. 25. Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nucleus Network
RECRUITINGMelbourne, Victoria, 3004, Australia
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