The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

This randomized, open-label, three-period, three-treatment crossover Phase I clinical trial is designed to evaluate the pharmacokinetic profile of QLC1101 capsules administered as a single oral dose under fasting conditions, following a high-fat meal, and following a low-fat meal in healthy adult subjects. The study will further characterize the food effect on QLC1101 pharmacokinetics. A total of 18 eligible subjects will be enrolled and randomized into three treatment sequences (A, B, C) using a balanced crossover design, with 6 subjects per sequence. The study comprises three treatment periods separated by appropriate washout intervals. In each period, subjects will receive a single dose of QLC1101 under one of three distinct dietary conditions according to their assigned sequence. Following completion of the first treatment period and a washout phase, subjects will crossover to the next dietary condition in the subsequent period, with this process repeating through all three study periods.

NCT Number	NCT06980909
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Effect of Food
Enrollment	18 participants
Start Date	2025-06
Primary Completion	2025-08 (estimated)
Study Completion	2025-08 (estimated)
Updated on ClinicalTrials.gov	2025-05-20