How food and a heartburn medicine change absorption of VRN101099
Official title: A Phase 1, Open-label, Randomized, 3-Period, 2-Sequence, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants
Run by Voronoi, Inc · NCT07550946 · Data updated 2026-11-12
This study tests how meals and a proton pump inhibitor affect how VRN101099 behaves in the body of healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Voronoi, Inc Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | September 1, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07550946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–65 without significant medical conditions and with suitable BMI/weight, not pregnant or breastfeeding, and willing to adhere to study procedures.
✕Probably not a fit
Participants in this study are healthy volunteers and may not directly benefit from the drug.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-centre, phase 1, randomized crossover study to see how food and a proton pump inhibitor (PPI) influence the pharmacokinetics of a 160 mg oral dose of VRN101099 in healthy adults. Thirty participants will undergo three treatment periods in different orders, with washouts between doses. Participants will have blood and urine samples collected to measure drug exposure and clearance, and will be monitored for safety throughout the study. The goal is to identify dosing conditions that optimize absorption for future patients with solid tumors and cancers.
Why it matters
Potential benefit: If successful, the study could inform how to best administer VRN101099 to improve its effectiveness and safety in cancer patients.
How similar studies have gone: Previous PK studies with similar oral agents and food/PPIs have demonstrated that such factors can alter absorption, guiding future dosing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Nucleus Network
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Anne Clark
- Email: a.clark@voronoi.io
- Phone: 19-434-8892
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.