Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN10… (NCT07550946) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants
Australia24 participantsStarted 2026-05-12
Plain-language 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.
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:
1. Does food or a PPI change how the body absorbs a single dose of VRN101099?
2. Is a single dose of VRN101099 safe and well tolerated when taken with or without food or a PPI?
3. How is VRN101099 removed through urine when taken with or without food or a PPI?
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓
What they're measuring
1
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
2
Plasma PK parameters- C24 (The concentration observed at 24 hours post-dose.)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
3
Plasma PK parameters- Cmax (Maximum observed plasma drug concentration (directly determined from the plasma concentration-time profiles).)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
4
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
5
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)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
6
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
. 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.
Exclusion criteria
✕. 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.
✕. 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.
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity)
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
8
Area under the plasma concentration versus time curve (AUC) in the presence or absence of high-fat, high-calorie food.
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
9
Peak Plasma Concentration (Cmax) in the presence or absence of high-fat, high-calorie food.
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
10
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).
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
11
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).
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
12
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).
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
13
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).
Timeframe: Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40