The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

NCT ID: NCT06980909

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

fasting, high-fat diet, low-fat diet

Group Type: EXPERIMENTAL

QLC1101

Intervention Type: 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 B

high-fat diet, low-fat diet, fasting

Group Type: EXPERIMENTAL

QLC1101

Intervention Type: 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 C

low-fat diet , fasting, high-fat diet

Group Type: EXPERIMENTAL

QLC1101

Intervention Type: 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.

Interventions

QLC1101

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.

Intervention Type: DRUG

QLC1101

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

Intervention Type: DRUG

QLC1101

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.

Intervention Type: DRUG

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wei Hu, PHD

Role: CONTACT

hwgcp@ayefy.com

13856086475

Other Identifiers

QLC1101-102

Identifier Type: -

Identifier Source: org_study_id