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?
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.
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.
Crossover
VRN101099
DrugType: Capsule form Route of administration: Oral
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
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
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
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
Incidence of TEAEs
Incidence of SAEs
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.
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.
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