Status:
RECRUITING
A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
Lead Sponsor:
Voronoi, Inc
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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....
Detailed Description
The study consists of two treatment sequences in a 3-period, crossover design. Approximately 24 healthy adult participants will be randomized 1:1 to one of the following sequences: Sequence 1: Partic...
Eligibility Criteria
Inclusion
- 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.
- Male participants must not donate sperm, and female participants must not donate ova, from the first dose through 6 months after the last dose.
- Able and willing to comply with study procedures and site visits.
- Able and willing to provide written informed consent before any study procedures are performed.
Exclusion
- 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.
- History of severe allergies or anaphylaxis, or known hypersensitivity to study drug components.
- Recent infections requiring parenteral antibiotics within 6 months before first dose.
- Vaccination with live vaccine within 4 weeks prior to first dose.
- Blood donation \>400 mL within 60 days, or component donation within 30 days prior to dosing.
- eGFR ≤ 90 mL/min/1.73 m² at screening.
- Use of nicotine-containing products within 7 days before dosing or unwillingness to abstain during the study.
- Use of prescription/OTC medications, herbal products, or supplements within 14 days prior to dosing, unless approved by the investigator.
- Use of CYP3A4 inhibitors/inducers or medications affecting metabolism of VRN110755 within 14 days prior to dosing.
- Unwillingness to follow dietary restrictions (e.g., cannot consume high-fat meals).
- Use of proton pump inhibitors, H2 blockers, or antacids within 8 weeks prior to first dose (except planned rabeprazole use in study).
- Known hypersensitivity to PPIs (e.g., rabeprazole).
- Planned or current participation in another investigational trial or use of another investigational product within 30 days or 5 half-lives.
- Poor peripheral venous access.
- Any condition that, in the opinion of the investigator, would jeopardize participant safety or interfere with study compliance or data integrity.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07141381
Start Date
August 27 2025
End Date
January 30 2026
Last Update
September 23 2025
Active Locations (1)
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1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000