Healthy AdultPhase 1NCT07550946

Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants

A Phase 1 study testing VRN101099 in people with Healthy Adult, run by Voronoi, Inc at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

This Clinical trial is being done to understand how food and a common stomach-acid reducing medicine (called a proton pump inhibitor-PPI) affect how the body absorbs a new drug, VRN101099, in healthy adults. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult
What is being tested?: VRN101099
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteAustralia
Study dates: 22 Jun 2026to 30 Sep 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female aged between 18 and 65 years of age (inclusive at the time of informed consent).
In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP (at the discretion of the PI or designee).
BMI between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at Screening.
Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator.
Female participants must be either not of childbearing potential or if they are a woman of childbearing potential and are engaged in heterosexual intercourse, they must agree to use an acceptable, highly effective contraception method in conjunction with a condom for the male partner from Screening until 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP).
Male participants must not be of childbearing potential, or if they are engaged in sexual relations with WOCBP, they must agree to use a condom in conjunction with an acceptable, highly effective contraception method for the female partner from Screening until 100 days after the last dose of the IP.

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Males must not donate sperm and females must not donate ova from the first dose of IP until at least 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP).
Able and willing to attend the necessary visits to the CRU.
Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Who cannot join

Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. This includes but may not be limited to: medical histories (eg, hepatic/biliary, renal, cardiovascular, endocrine, respiratory, digestive, haematologic, oncologic [except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to the first administration of IP], central nervous system, psychiatric, musculoskeletal) or past medical/surgical histories that may affect drug absorption, distribution, metabolism, or excretion (excluding simple appendectomy or herniorrhaphy).
Participants with known or suspected conditions or significant gastrointestinal disorders that may interfere with drug absorption (eg, inflammatory bowel disease, chronic diarhoea, malabsorption syndromes, or prior gastrointestinal surgery affecting absorption).
History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
History of hypersensitivity and/or intolerance to PPIs.
History of infections requiring parenteral antibiotics within 6 months prior to the first administration of IP.
Blood donations of ≥ 400 mL or significant blood loss within 60 days prior to the first administration of investigational product (IP), plasma donation within 7 days prior to the first administration of IP, or platelet donation within 30 days prior to the first administration of IP. Participants must also agree not to donate blood, plasma, or platelets during the study and for at least 30 days after the last dose of IP.

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Abnormal findings on 12-lead (triplicate) ECG at Screening that are considered by the PI or designee to be clinically significant; or has a QTcF (Fridericia's formula) interval at Screening of > 450 msec for males or > 470 msec for females based on the average of the 3 readings. Repeat testing at Screening is acceptable for abnormal values at the discretion of the Investigator (once per parameter).
Abnormal vital sign findings at Screening that are considered clinically significant by the Principal Investigator (PI) or designee, including systolic blood pressure >140 mmHg or < 90 mmHg, diastolic blood pressure > 90 mmHg or < 50 mmHg, or a history of symptomatic hypotension. If a screening value falls outside these limits, repeat measurement is permitted at the discretion of the Investigator, with one repeat assessment allowed per parameter. Eligibility should be based on the repeat value.
Active liver disease, or AST and/or ALT > 1.5 × upper limit of normal at Screening. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator.
Estimated glomerular filtration rate (eGFR) of ≤ 80 mL/min/ 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula.
Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device), within 14 days prior to the first administration of the IP; or use of any over the counter medication, herbal remedies, supplements, or vitamins within 7 days prior to the first administration of IP and during course of study. Note: Simple analgesia (eg, paracetamol) may be permitted at the discretion of the PI, provided they are used within the recommended maximum daily doses as specified in the package insert.
Use of any drugs, herbal supplements, or foods that are known to be strong or moderate inhibitors/inducers of CYP3A4 (eg, carbamazepine, rifampin, St. John's wort, ketoconazole, ginkgo biloba, grapefruit, grapefruit juice) from within 30 days prior to the first administration of IP until the end of the study.
Use of PPIs, histamine (H)2 blockers, potassium-competitive acid blockers, or locally-acting antacids within 8 weeks before the first dose of IP, or requiring these medications during the study (except for the planned use of rabeprazole specified in the protocol)
Vaccination with a live vaccine within 4 weeks prior to the first administration of IP (and up until 14 days after the last dose of the IP).
Use of any IP or investigational medical device within 30 days prior to the first administration of IP, or 5 half lives of the product (whichever is the longest), and during the course of the study.
Positive toxicology screening panel (urine test including qualitative identification of amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, and tricyclic antidepressants), or alcohol breath test at Screening. Note: A single repeat test in the event of a false positive is permitted for the drug of abuse urine test at the discretion of the Investigator.
History of regular alcohol consumption defined as > 14 standard drinks per week or > 3 standard drinks on any single day (where 1 standard drink = 10 g of alcohol) within 3 months prior to Screening.
Unwilling or unable to abstain from the consumption of alcohol and caffeine containing food or drinks beginning 72 hours prior to the first administration of IP and until the end of the study.
Unwilling to abstain from cigarettes or nicotine-containing products (eg, cigars, vapes, nicotine patches) for at least 7 days prior to first IP administration through to the end of the study, or is considered to be dependent on nicotine at the discretion of the PI. Note: Participants that are considered light or social smokers (defined as ≤ 5 cigarettes per week) will be considered eligible for entry into the study but must also adhere to these restrictions.
Unwilling to refrain from strenuous exercise (including weightlifting) from 48 hours prior to each admission (on Day -1, Day 11, and Day 28), during the inpatient stays, and for 48 hours prior to any outpatient visit (including the EOS visit).
Unable or unwilling to consume a high-fat meal.
Pregnant or lactating.
Poor peripheral venous access.
Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne Clark contact

19-434-8892 ext. +19

a.clark@voronoi.io

Australia1 site, 1 recruiting

Nucleus Network
Melbourne, Victoria, 3004
Dr. Victor Wong, 85939801 ext. 03, v.wong@nucleusnetwork.com.au
Dr. Victor Wong
Recruiting

Other trials in Australia

About this study

Official title: A Phase 1, Open-label, Randomized, 3-Period, 2-Sequence, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants

Researchers will measure how much of the drug gets into the bloodstream and how fast it gets there in each situation.

This will help identify the most effective way for future patients to use VRN101099 in the treatment of solid tumors and cancers.

The main questions it aims to answer is:

Does food or a PPI change how the body absorbs a single dose of VRN101099?
Is a single dose of VRN101099 safe and well tolerated when taken with or without food or a PPI?
How is VRN101099 removed through urine when taken with or without food or a PPI?

Read the detailed description

This is a single-centre, 3-period, 2-sequence, open-label, randomized, crossover study to evaluate the effect of food and a PPI on the PK of a 160 mg oral dose of VRN101099 in healthy adult participants. The study will consist of approximately 24 participants, who will be enrolled and then randomized 1:1 into 2 cohorts (sequences).

This is a 3-period, 2-sequence, crossover study, which means every participant will receive VRN101099 three times-once in each condition, but in different orders depending on their assigned sequence.

Participants will be randomly assigned to one of two sequences:

Sequence 1: Fasted → Fed → Fed + PPI Sequence 2: Fed → Fasted → Fasted + PPI

All participants will take the same dose of VRN101099, but under different conditions:

once after eating a meal,
once while taking a PPI,
and once on an empty stomach.

Each dose of VRN101099 will be 160 mg and taken once per period. There will be at least 7 days of washout between doses.

Blood samples may be taken up to 240 hours (10 days) after each dose to measure drug levels

Urine samples will be collected for 24 hours after each dose

Participants will be monitored for side effects and general safety throughout the study.

Conditions: Healthy Adult
Being tested: VRN101099

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRN101099Drug
Type: Capsule form Route of administration: Oral

Study groups in NCT07550946
Study group	Role	What they receive
VRN101099-Sequence A	Experimental	Unit Dose: 40 milligram + 120 milligram capsules Route of Administration: Oral (Capsules) Participants will receive a total oral dose of 160 mg of the investigational product administered as two capsules taken together, consisting of one 40 mg capsule (size 4, white opaque) and one 120 mg capsule, to achieve the required 160 mg dose. Receives: Drug: VRN101099
VRN101099-Sequence B	Experimental	Unit Dose: 40 milligram + 120 milligram capsules Route of Administration: Oral (Capsules) Participants will receive a total oral dose of 160 mg of the investigational product administered as two capsules taken together, consisting of one 40 mg capsule (size 4, white opaque) and one 120 mg capsule, to achieve the required 160 mg dose. Receives: Drug: VRN101099

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- C24 (The concentration observed at 24 hours post-dose.)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration (directly determined from the plasma concentration-time profiles).)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- AUC0-24 (Area under the plasma concentration-time curve, from time zero (time of dosing) to 24 hours post-dose with measurable analyte concentration, calculated by 'the linear up and log down' method)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity)
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Area under the plasma concentration versus time curve (AUC) in the presence or absence of high-fat, high-calorie food.
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) in the presence or absence of high-fat, high-calorie food.
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Area under the plasma concentration versus time curve (AUC) in the presence or absence of Proton pump inhibitor (PPI) in fasting conditions (fasted PK data comparison in Period 3 and Period 2 for Sequence 2 participants).
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) in the presence or absence of Proton pump inhibitor (PPI) in fasting conditions (fasted PK data comparison in Period 3 and Period 2 for Sequence 2 participants).
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Area under the plasma concentration versus time curve (AUC) in the presence or absence of Proton pump inhibitor (PPI) in fed conditions (fed PK data comparison in Period 3 and Period 2 for Sequence 1 participants).
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) ratios in the presence or absence of Proton pump inhibitor (PPI) in fed conditions (fed PK data comparison in Period 3 and Period 2 for Sequence 1 participants).
Measured: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40

Secondary outcomes (6)

Incidence of TEAEs
Measured: Day 1 to Day 41 (EOS-End of study visit)
Incidence of SAEs
Measured: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal vital signs
Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate.
Vital signs are to be taken after the participant has rested in the supine position for ≥ 5 minutes. Vital signs will be measured in triplicates at approximately 2-minute intervals at Day 1, Day 12, and Day 29 (pre-dose). The averages of these triplicate measurements will be used to assess suitability for dosing as well as to determine if a repeat measurement is required.
Measured: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal Physical examination findings
Complete physical examinations include general appearance, mouth/dental (if required), neck (including thyroid \& nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, other.
Measured: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal laboratory tests results
Hematology, clinical chemistry, Coagulation and urinalysis parameters will be assessed at scheduled visits
Measured: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal ECG readings
12 Lead ECG: Triplicate readings to be taken within 2 to 5 minutes of each other.
ECGs are to be taken after the participant has rested in the supine position for ≥ 5 minutes.
Measured: Day 1 to Day 41 (EOS-End of study visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202630 Sep 2026

First posted24 Apr 2026
Study start22 Jun 2026
Primary completion1 Sep 2026 (estimated)
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07550946
Sponsor's protocol ID: VRN101099-001
Status last verified: Aug 2026
First submitted: 9 Apr 2026
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Anne Clark

19-434-8892 ext. +19

a.clark@voronoi.io

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, 3-Period, 2-Sequence, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07550946
Acronym / sponsor ID: VRN101099-001
Conditions: Healthy Adult
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Voronoi, IncIndustry (pharma, biotech, devices)
Study start: 22 Jun 2026 (actual)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 30 Sep 2026 (estimated)
First posted: 24 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Researchers will measure how much of the drug gets into the bloodstream and how fast it gets there in each situation.

This will help identify the most effective way for future patients to use VRN101099 in the treatment of solid tumors and cancers.

The main questions it aims to answer is:

Does food or a PPI change how the body absorbs a single dose of VRN101099?
Is a single dose of VRN101099 safe and well tolerated when taken with or without food or a PPI?
How is VRN101099 removed through urine when taken with or without food or a PPI?

Detailed description

This is a 3-period, 2-sequence, crossover study, which means every participant will receive VRN101099 three times-once in each condition, but in different orders depending on their assigned sequence.

Participants will be randomly assigned to one of two sequences:

Sequence 1: Fasted → Fed → Fed + PPI Sequence 2: Fed → Fasted → Fasted + PPI

All participants will take the same dose of VRN101099, but under different conditions:

once after eating a meal,
once while taking a PPI,
and once on an empty stomach.

Each dose of VRN101099 will be 160 mg and taken once per period. There will be at least 7 days of washout between doses.

Blood samples may be taken up to 240 hours (10 days) after each dose to measure drug levels

Urine samples will be collected for 24 hours after each dose

Participants will be monitored for side effects and general safety throughout the study.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VRN101099-Sequence A	Experimental	Drug: VRN101099Unit Dose: 40 milligram + 120 milligram capsules Route of Administration: Oral (Capsules) Participants will receive a total oral dose of 160 mg of the investigational product administered as two capsules taken together, consisting of one 40 mg capsule (size 4, white opaque) and one 120 mg capsule, to achieve the required 160 mg dose.
VRN101099-Sequence B	Experimental	Drug: VRN101099Unit Dose: 40 milligram + 120 milligram capsules Route of Administration: Oral (Capsules) Participants will receive a total oral dose of 160 mg of the investigational product administered as two capsules taken together, consisting of one 40 mg capsule (size 4, white opaque) and one 120 mg capsule, to achieve the required 160 mg dose.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female aged between 18 and 65 years of age (inclusive at the time of informed consent).
In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP (at the discretion of the PI or designee).
BMI between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at Screening.
Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator.
Female participants must be either not of childbearing potential or if they are a woman of childbearing potential and are engaged in heterosexual intercourse, they must agree to use an acceptable, highly effective contraception method in conjunction with a condom for the male partner from Screening until 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP).

Key exclusion criteria (25 listed)

Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. This includes but may not be limited to: medical histories (eg, hepatic/biliary, renal, cardiovascular, endocrine, respiratory, digestive, haematologic, oncologic [except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to the first administration of IP], central nervous system, psychiatric, musculoskeletal) or past medical/surgical histories that may affect drug absorption, distribution, metabolism, or excretion (excluding simple appendectomy or herniorrhaphy).
Participants with known or suspected conditions or significant gastrointestinal disorders that may interfere with drug absorption (eg, inflammatory bowel disease, chronic diarhoea, malabsorption syndromes, or prior gastrointestinal surgery affecting absorption).
History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
History of hypersensitivity and/or intolerance to PPIs.
History of infections requiring parenteral antibiotics within 6 months prior to the first administration of IP.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRN101099Type: Capsule form Route of administration: Oral	Drug	VRN101099-Sequence A, VRN101099-Sequence B

Primary outcome

Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- C24 (The concentration observed at 24 hours post-dose.)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration (directly determined from the plasma concentration-time profiles).)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- AUC0-24 (Area under the plasma concentration-time curve, from time zero (time of dosing) to 24 hours post-dose with measurable analyte concentration, calculated by 'the linear up and log down' method)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity)
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
The mixed model for repeated measures (MMRM) will be performed on the natural-log (ln)-transformed PK parameters
Area under the plasma concentration versus time curve (AUC) in the presence or absence of high-fat, high-calorie food.
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) in the presence or absence of high-fat, high-calorie food.
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Area under the plasma concentration versus time curve (AUC) in the presence or absence of Proton pump inhibitor (PPI) in fasting conditions (fasted PK data comparison in Period 3 and Period 2 for Sequence 2 participants).
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) in the presence or absence of Proton pump inhibitor (PPI) in fasting conditions (fasted PK data comparison in Period 3 and Period 2 for Sequence 2 participants).
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Area under the plasma concentration versus time curve (AUC) in the presence or absence of Proton pump inhibitor (PPI) in fed conditions (fed PK data comparison in Period 3 and Period 2 for Sequence 1 participants).
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Peak Plasma Concentration (Cmax) ratios in the presence or absence of Proton pump inhibitor (PPI) in fed conditions (fed PK data comparison in Period 3 and Period 2 for Sequence 1 participants).
Time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40

6 secondary outcomes

Incidence of TEAEs
Time frame: Day 1 to Day 41 (EOS-End of study visit)
Incidence of SAEs
Time frame: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal vital signs
Time frame: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal Physical examination findings
Time frame: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal laboratory tests results
Time frame: Day 1 to Day 41 (EOS-End of study visit)
Number of participants with abnormal ECG readings
Time frame: Day 1 to Day 41 (EOS-End of study visit)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Anne Clark contact

19-434-8892 ext. +19

a.clark@voronoi.io

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRN101099 in people with Healthy Adult, run by Voronoi, Inc at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Clark (19-434-8892 ext. +19, a.clark@voronoi.io), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.) (time frame: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.