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 range18 Years – 65 Years
SexALL
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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.
✓. 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).
What they're measuring
1
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCâ‚€-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)
✕. 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.