A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN… (NCT07141381) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
Australia25 participantsStarted 2025-08-27
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC₀-inf) of VRN110755
Timeframe: Up to 312 hours post-dose (for each treatment period)
2
Maximum Observed Plasma Concentration (Cmax) of VRN110755
Timeframe: Up to 312 hours post-dose (for each treatment period)
3
Time to Maximum Observed Concentration (Tmax) of VRN110755
Timeframe: Up to 312 hours post-dose (for each treatment period)
4
Comparison of Pharmacokinetic Parameters (AUC and Cmax Ratios) Across Treatment Conditions
Timeframe: Up to 312 hours post-dose (for each treatment period)
. 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.
Exclusion criteria
. 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.
. Regular alcohol use \>14 standard drinks/week or \>3 drinks/day.
. Positive test for HIV, Hepatitis B (HBsAg), or Hepatitis C antibody.