Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants
Condition(s) studied
Investigational drug(s) / intervention(s)
VRN101099: Type: Capsule form Route of administration: Oral
Study 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?
Eligibility
Primary outcome measure(s)
- Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.) — 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.) — 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).) — 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) — 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) — 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) — 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) — 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. — 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. — 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). — 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). — 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). — 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). — Day 1,2,3,4,7,11,12,13,14,15,19,23,29,30,31,32,36,40
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07550946 on ClinicalTrials.gov ↗ ← All trials in Australia