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Not yet recruiting NCT06980909

The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

Phase I Interventional Effect of Food

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLC1101, QLC1101, QLC1101.
Who it may be relevant to
Registry conditions: Effect of Food. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-dose, Randomized, Open-label, Three-period, Crossover Pharmacokinetic Study of QLC1101 in Healthy Subjects in the Fasting and Fed State

Overview

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

  • 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.
  • 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
  • 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.

Primary outcome measures

  • Cmax [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]
  • AUC [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]
  • Tmax [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]
  • t1/2 [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]
  • CL/F [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]
  • VZ/F [Time frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06980909 · QLC1101-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗