Phase I Study to Assess Food Effects and Bioavailability of ECC4703 Drug Formulations in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are studying the effects of food on the absorption and availability of different ECC4703 drug formulations in healthy adults. This Phase I, open-label, randomized study aims to understand how food influences the drugs behavior in the body by comparing various formulations in single-dose treatments. The study involves healthy adults aged 18 to 65 years with no significant health conditions. The study has two parts. Part 1 involves three groups of 16 participants each who will receive single doses of ECC4703 formulations F1, F2, and F3 in both high-fat and fasted states to assess food effects. Part 2 will enroll about 24 participants to compare selected formulations from Part 1 with formulation F0, using an adaptive design to determine treatment sequences and conditions. Participants receive the drug in specific sequences to measure how food affects drug absorption. Participants will undergo assessments including physical exams, vital signs, ECGs, and laboratory tests to monitor health and drug effects. Researchers will measure pharmacokinetic parameters such as drug concentration over time, peak concentration, and elimination rates up to 13 days after dosing. Safety evaluations include monitoring adverse events and clinical tests up to 18 days. Participants involvement includes multiple visits for dosing and follow-up assessments during the study period.

ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants