The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects
- Registration Number
- NCT06980909
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg.
- BMI is within the range of 18.0~28.0 kg/m2 (including the boundary value).
- Those who have a history of allergies to drugs, food, pollen, or other clear allergies, or those who are allergic to the experimental drugs and their ingredients;
- Patients with dysphagia or any disease that affects drug absorption, distribution, metabolism and excretion, especially those with a history of gastrointestinal diseases (such as gastric ulcer, gastric bleeding, long-term diarrhea, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A QLC1101 fasting, high-fat diet, low-fat diet Group B QLC1101 high-fat diet, low-fat diet, fasting Group C QLC1101 low-fat diet , fasting, high-fat diet
- Primary Outcome Measures
Name Time Method Cmax 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Maximum plasma concentration of QLC1101
AUC 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Area under the concentration-time curve of QLC1101.
Tmax 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Time of maximum observed concentration of QLC1101
t1/2 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Terminal elimination half-life of QLC1101
CL/F 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Apparent total clearance of the drug from plasma after oral administration of QLC1101
VZ/F 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose Apparent volume of distribution after oral administration of QLC1101.
- Secondary Outcome Measures
Name Time Method