CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000, Australia
NCT Number: NCT07141381
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Adelaide, South Australia, 5000, Australia
The study consists of two treatment sequences in a 3-period, crossover design. Approximately 24 healthy adult participants will be randomized 1:1 to one of the following sequences:
Sequence 1: Participants will receive VRN110755 80 mg orally in the fasted state (Period 1), then in the fed state (Period 2), and finally in the fed state with 5 days of rabeprazole pre-treatment (Period 3).
Sequence 2: Participants will receive VRN110755 80 mg orally in the fed state (Period 1), then in the fasted state (Period 2), and finally in the fasted state with 5 days of rabeprazole pre-treatment (Period 3).
Rabeprazole 20 mg will be administered orally once daily for 5 consecutive days prior to the final dosing of VRN110755 in Period 3.
All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood and urine samples will be collected at defined intervals for the analysis of VRN110755 and its metabolites.
Each participant's total study duration will be approximately 76 days, including screening, treatment, and follow-up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to 312 hours post-dose (for each treatment period)
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.
Time frame: Up to 312 hours post-dose (for each treatment period)
To assess the peak plasma concentration of VRN110755 under different dosing conditions (fasted, fed, fed/fasted + PPI).
Time frame: Up to 312 hours post-dose (for each treatment period)
To assess the time to reach peak concentration of VRN110755 after single-dose oral administration under different conditions.
Time frame: Up to 312 hours post-dose (for each treatment period)
To compare AUC and Cmax values of VRN110755 between fed vs. fasted, and PPI vs. non-PPI conditions using statistical analysis.
Time frame: From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
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.
Time frame: From Day 1 of Period 1 through the End of Study (approximately 76 days per participant)
To monitor and document any SAEs occurring after VRN110755 administration under any treatment condition.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)
The number of participants exhibiting abnormal laboratory values in hematology, biochemistry, coagulation, or urinalysis assessments..
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48)
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.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
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.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
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.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
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.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
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.
Time frame: Baseline (Day 1), pre-dose on Day 15 and Day 34, and End-of-Study Visit (Day 48).
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.
Time frame: 0 to 24 hours post-dose in each study period.
Cumulative amount of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Time frame: 0 to 24 hours post-dose in each study period.
Fraction of the administered dose of VRN110755 excreted in urine, measured over 0 to 24 hours post-dose under different study conditions.
Time frame: 0 to 24 hours post-dose in each study period.
Renal clearance of VRN110755, determined from urinary excretion and plasma concentration data under different study conditions.
Voronoi, Inc
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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