The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Effect of Food

Treatments: Drug: QLC1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06980909

QLC1101-102

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Group A

Experimental group

Description:

fasting, high-fat diet, low-fat diet

Treatment:

Drug: QLC1101

Drug: QLC1101

Drug: QLC1101

Group B

Experimental group

Description:

high-fat diet, low-fat diet, fasting

Treatment:

Drug: QLC1101

Drug: QLC1101

Drug: QLC1101

Group C

Experimental group

Description:

low-fat diet , fasting, high-fat diet

Treatment:

Drug: QLC1101

Drug: QLC1101

Drug: QLC1101