Effect of Food
Conditions
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.
Interventions
DRUGQLC1101
QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactWei Hu, PHD
Outcome results
None listed