The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

NCT06980909 | Not Yet Recruiting Phase 1

• 1 other identifier: QLC1101-102
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Effect of Food

Outcome Measures

Primary Outcomes (6)

• Cmax

  Maximum plasma concentration of QLC1101

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

• AUC

  Area under the concentration-time curve of QLC1101.

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

• Tmax

  Time of maximum observed concentration of QLC1101

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

• t1/2

  Terminal elimination half-life of QLC1101

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

• CL/F

  Apparent total clearance of the drug from plasma after oral administration of QLC1101

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

• VZ/F

  Apparent volume of distribution after oral administration of QLC1101.

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose

Study Arms (3)

Group A

EXPERIMENTAL

fasting, high-fat diet, low-fat diet

Drug: QLC1101

Group B

EXPERIMENTAL

high-fat diet, low-fat diet, fasting

Drug: QLC1101

Group C

EXPERIMENTAL

low-fat diet , fasting, high-fat diet

Drug: QLC1101

Interventions

QLC1101 DRUG

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.

Group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Wei Hu, PHD

CONTACT

13856086475; hwgcp@ayefy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05