Healthy volunteers help test how food and acid pills affect new drug absorption
NCT ID NCT07141381
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how taking VRN110755 with food or with a common stomach-acid drug (rabeprazole) changes the amount of drug in the blood. Twenty-five healthy adults took the drug under different conditions. The goal was to learn the best way to take the medicine in future studies.
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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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25 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
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Apr 2026
- 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
-
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 participants aged between 18 and 65 years, inclusive, at the time of informed consent. 2. In good general health, with no significant medical history and no clinically significant abnormalities on physical examination, as determined by the investigator. 3. Body mass index (BMI) between 18.0 and 32.0 kg/m², and weight ≥ 50 kg at screening. 4. Clinical laboratory values within normal ranges, unless deemed not clinically significant by the investigator. 5. 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. 6. Female participants must have a negative pregnancy test at screening and pre-dose. 7. Women not of childbearing potential must be surgically sterile or postmenopausal for ≥12 months. 8. 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. 9. Male participants must not donate sperm, and female participants must not donate ova, from the first dose through 6 months after the last dose. 10. Able and willing to comply with study procedures and site visits. 11. Able and willing to provide written informed consent before any study procedures are performed. Exclusion Criteria: 1. Any significant medical or psychiatric condition that may interfere with study participation or interpretation of results, as determined by the investigator. 2. Clinically significant abnormal ECG findings, including QTcF \> 450 ms (males) or \> 470 ms (females). 3. Abnormal vital signs at screening (e.g., systolic BP \> 140 or \< 90 mmHg, diastolic BP \> 90 or \< 60 mmHg, or history of symptomatic hypotension). 4. Active liver disease, or AST/ALT \> 1.5 × upper limit of normal. 5. Known or suspected gastrointestinal disorders that may interfere with drug absorption (e.g., IBD, chronic diarrhea, malabsorption). 6. Positive urine drug screen or alcohol breath test at screening. 7. Regular alcohol use \>14 standard drinks/week or \>3 drinks/day. 8. Positive test for HIV, Hepatitis B (HBsAg), or Hepatitis C antibody. 9. History of severe allergies or anaphylaxis, or known hypersensitivity to study drug components. 10. Recent infections requiring parenteral antibiotics within 6 months before first dose. 11. Vaccination with live vaccine within 4 weeks prior to first dose. 12. Blood donation \>400 mL within 60 days, or component donation within 30 days prior to dosing. 13. eGFR ≤ 90 mL/min/1.73 m² at screening. 14. Use of nicotine-containing products within 7 days before dosing or unwillingness to abstain during the study. 15. Use of prescription/OTC medications, herbal products, or supplements within 14 days prior to dosing, unless approved by the investigator. 16. Use of CYP3A4 inhibitors/inducers or medications affecting metabolism of VRN110755 within 14 days prior to dosing. 17. Unwillingness to follow dietary restrictions (e.g., cannot consume high-fat meals). 18. Use of proton pump inhibitors, H2 blockers, or antacids within 8 weeks prior to first dose (except planned rabeprazole use in study). 19. Known hypersensitivity to PPIs (e.g., rabeprazole). 20. Planned or current participation in another investigational trial or use of another investigational product within 30 days or 5 half-lives. 21. Poor peripheral venous access. 22. Any condition that, in the opinion of the investigator, would jeopardize participant safety or interfere with study compliance or data integrity.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000, Australia
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