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TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

A Randomized, Open-label, Single-dose, 3-cycle, 6-sequence, Crossover Study Evaluating Food Effect on Pharmacokinetic Profiles of TGRX-326 in Chinese Healthy Subjects and Effect of Drug Specification on Bioavailability in Human

NCT06304805•Shenzhen TargetRx Co., Ltd.

View on ClinicalTrials.gov

Summary

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment

Detailed Description

This study is designed as single-center, randomized, open-label, 3-cycle, 6-sequence and crossover design to evaluate 1) food effect on PK profile of TGRX-326; 2) effect of different specifications of TGRX-326 on human bioavailability. Safety for food effect on TGRX-326 and safety for different TGRX-326 specifications were also evaluated.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•able to understand the purpose, methods and possible adverse events of the study and agree to volunteering consent before the start of study
•healthy subject; male or female
•Age between 18 and 55 (inclusive)
•body mass index (BMI) between 19.0 and 26.0 (inclusive), male weight \<=50 kg, female weight \<=45 kg
•normal/ clinically insignificant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
•participant/partner of the participant does not have plans for child bearing from screening until 6 months after study, and is willing to take contraceptive measures during study period and for 6 months, and does not have plans to donate sperm/egg during the said period

Exclusion Criteria

•history of allergic reactions, or allergic to any components to the study drugs that by investigator's judgement unsuitable for the study
•any clinically significant conditions that could affect study outcomes, safety or compliance
•history of major surgery within 3 months before first dose, or have plans to receive surgery during the study, or history of any surgery that could affect drug absorption, distribution, metabolism and excretion
•have difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
•history of substance abuse
•have special food requirement or cannot follow food requirement of the study, or lactose intolerant
•use of any investigational drug or participation of any clinical study (for drug or medical device) within 3 months before first dose, or cannot participate the study in person/on site
•history of blood donation, blood loss (\>= 400 mL, excluding normal blood loss during female menstrual period), or reception of blood transfusion within 3 months before screening
•history of daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
•history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or cannot avoid alcohol consumption during study
+11 more criteria

Locations (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, China

Key Dates

Start Date

December 13, 2023

Primary Completion Date

January 12, 2024

Completion Date

January 19, 2024

Last Updated

May 18, 2025

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

cycle 1: treatment drug

DRUG

cycle 1: reference drug

DRUG

cycle 1: fasted

BEHAVIORAL

cycle 1: food

BEHAVIORAL

cycle 2: treatment drug

DRUG

cycle 2: reference drug

DRUG

cycle 2: fasted

BEHAVIORAL

cycle 2: food

BEHAVIORAL

cycle 3: treatment drug

DRUG

cycle 3: reference drug

DRUG

cycle 3: fasted

BEHAVIORAL

cycle 3: food

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)