Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07141381
Registration number
NCT07141381
Ethics application status
Date submitted
24/07/2025
Date registered
26/08/2025
Date last updated
26/08/2025
Titles & IDs
Public title
A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755
Query!
Scientific title
A Phase 1, Open-label, 3-Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 in Healthy Adult Participants
Query!
Secondary ID [1]
0
0
VRN110755-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Healthy
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - VRN110755
Treatment: Drugs - Rabeprazole
Experimental: Sequence 1: Fasted ? Fed ? Fed with PPI - Participants in this sequence will receive VRN110755 80 mg orally under the following conditions across three periods:
Period 1: Fasted state Period 2: Fed state (standard high-fat meal) Period 3: Fed state after 5 days of rabeprazole 20 mg daily
Experimental: Sequence 2: Fed ? Fasted ? Fasted with PPI - Participants in this sequence will receive VRN110755 80 mg orally under the following conditions across three periods:
Period 1: Fed state (standard high-fat meal) Period 2: Fasted state Period 3: Fasted state after 5 days of rabeprazole 20 mg daily
Treatment: Drugs: VRN110755
VRN110755 is an investigational EGFR inhibitor administered as an 80 mg oral capsule. It will be given to all participants under fasted, fed, and PPI pre-treated conditions across three periods in a crossover design.
Treatment: Drugs: Rabeprazole
Rabeprazole 20 mg will be administered orally once daily for 5 days prior to VRN110755 dosing in Period 3. This is to assess the effect of increased gastric pH (via proton pump inhibition) on the pharmacokinetics of VRN110755.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of VRN110755
Query!
Assessment method [1]
0
0
To evaluate the effect of food and rabeprazole on the extent of systemic exposure of VRN110755 by measuring AUC0-inf under fasted, fed, and PPI conditions.
Query!
Timepoint [1]
0
0
Up to 312 hours post-dose (for each treatment period)
Query!
Primary outcome [2]
0
0
Maximum Observed Plasma Concentration (Cmax) of VRN110755
Query!
Assessment method [2]
0
0
To assess the peak plasma concentration of VRN110755 under different dosing conditions (fasted, fed, fed/fasted + PPI).
Query!
Timepoint [2]
0
0
Up to 312 hours post-dose (for each treatment period)
Query!
Primary outcome [3]
0
0
Time to Maximum Observed Concentration (Tmax) of VRN110755
Query!
Assessment method [3]
0
0
To assess the time to reach peak concentration of VRN110755 after single-dose oral administration under different conditions.
Query!
Timepoint [3]
0
0
Up to 312 hours post-dose (for each treatment period)
Query!
Primary outcome [4]
0
0
Comparison of Pharmacokinetic Parameters (AUC and Cmax Ratios) Across Treatment Conditions
Query!
Assessment method [4]
0
0
To compare AUC and Cmax values of VRN110755 between fed vs. fasted, and PPI vs. non-PPI conditions using statistical analysis.
Query!
Timepoint [4]
0
0
Up to 312 hours post-dose (for each treatment period)
Query!
Secondary outcome [1]
0
0
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
To evaluate the safety and tolerability of single oral doses of VRN110755 administered under fasted, fed, and PPI conditions by assessing the incidence, severity, and relationship of TEAEs.
Query!
Timepoint [1]
0
0
From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
Query!
Secondary outcome [2]
0
0
Incidence of Serious Adverse Events (SAEs)
Query!
Assessment method [2]
0
0
To monitor and document any SAEs occurring after VRN110755 administration under any treatment condition.
Query!
Timepoint [2]
0
0
From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
Query!
Secondary outcome [3]
0
0
Number of Participants with Abnormal Clinical Laboratory Test Results
Query!
Assessment method [3]
0
0
The number of participants exhibiting abnormal laboratory values in hematology, biochemistry, coagulation, or urinalysis assessments..
Query!
Timepoint [3]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)
Query!
Secondary outcome [4]
0
0
Change in 12-lead ECG Parameters From Baseline
Query!
Assessment method [4]
0
0
Change from baseline in ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcF (Fridericia). ECGs will be recorded after at least 5 minutes of rest in the supine position. Triplicate ECGs will be taken at screening; single ECGs will be performed at other scheduled timepoints unless clinically indicated.
Query!
Timepoint [4]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)
Query!
Secondary outcome [5]
0
0
Change in Systolic Blood Pressure From Baseline
Query!
Assessment method [5]
0
0
Change from baseline in systolic blood pressure measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Query!
Timepoint [5]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Query!
Secondary outcome [6]
0
0
Change in Diastolic Blood Pressure From Baseline
Query!
Assessment method [6]
0
0
Change from baseline in diastolic blood pressure measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Query!
Timepoint [6]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Query!
Secondary outcome [7]
0
0
Change in Pulse Rate From Baseline
Query!
Assessment method [7]
0
0
Change from baseline in pulse rate measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Query!
Timepoint [7]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Query!
Secondary outcome [8]
0
0
Change in Respiratory Rate From Baseline
Query!
Assessment method [8]
0
0
Change from baseline in respiratory rate measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Query!
Timepoint [8]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Query!
Secondary outcome [9]
0
0
Change in Tympanic Temperature From Baseline
Query!
Assessment method [9]
0
0
Change from baseline in tympanic temperature measured after at least 5 minutes of rest in the supine position. Triplicate readings will be performed at pre-dose; single measurements at other scheduled timepoints.
Query!
Timepoint [9]
0
0
Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
Query!
Secondary outcome [10]
0
0
Cumulative Amount Excreted (Ae) of VRN110755
Query!
Assessment method [10]
0
0
Cumulative amount of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Query!
Timepoint [10]
0
0
0 to 24 hours post-dose in each study period.
Query!
Secondary outcome [11]
0
0
Fraction Excreted (Fe) of VRN110755
Query!
Assessment method [11]
0
0
Fraction of the administered dose of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Query!
Timepoint [11]
0
0
0 to 24 hours post-dose in each study period.
Query!
Secondary outcome [12]
0
0
Renal Clearance (CLr) of VRN110755
Query!
Assessment method [12]
0
0
Renal clearance of VRN110755, determined from urinary excretion and plasma concentration data under different study conditions.
Query!
Timepoint [12]
0
0
0 to 24 hours post-dose in each study period.
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
25/08/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/01/2026
Query!
Actual
Query!
Sample size
Target
24
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
CMAX Clinical Research Pty Ltd - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Voronoi, Inc
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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. 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT07141381
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Rutu Dabhi
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1 201-515-9340
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07141381
Download to PDF