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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06304805
Other study ID # TGRX-326-1002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 13, 2023
Est. completion date January 19, 2024

Study information

Verified date April 2024
Source Shenzhen TargetRx, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 19, 2024
Est. primary completion date January 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 - history of large tea/coffee/caffeinated drink intake (more than 8 cups per day) within 3 months before first dose - history of irregular dietary schedule within 1 months of first dose (including, dieting, overeating, low sodium intake, etc.) - use of any prescription / over-the-counter drug, or Chinese herbal medication, or health supplementary products within 14 days of test article administration - vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period - any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody - alcohol breathing test results of > 0.0 mg/100mL for blood alcohol concentration - positive test results on substance use (including, morphine, methylamphetamine, ketamine, tetrahydrocannabinol, methylene-dioxy-methyl-amphetamine) - female in pregnancy or breastfeeding period, or positive pregnancy test result - history of unprotected sexual activities within 14 days before first dose - consumption of food or drink rich in caffeine/xanthine (such as chocolate, coffee, tea, coke) or food/food product of grapefruit, dragon fruit, mango, tangerine, or any food that could affect drug absorption, distribution, metabolism and excretion - any reasons that is deemed unsuitable for study participation as determined by investigator

Study Design


Intervention

Drug:
cycle 1: treatment drug
for cycle 1 treatment: participants are given the oral treatment specification (60 mg *1 pill)
cycle 1: reference drug
for cycle 1 treatment: participants are given the oral reference specification (5 mg *2 pills + 25 mg * 2 pills)
Behavioral:
cycle 1: fasted
for cycle 1 treatment: participants are asked to take the drug fasted
cycle 1: food
for cycle 1 treatment: participants are asked to take the drug after food intake
Drug:
cycle 2: treatment drug
for cycle 2 treatment: participants are given the oral treatment specification (60 mg *1 pill)
cycle 2: reference drug
for cycle 2 treatment: participants are given the oral reference specification (5 mg *2 pills + 25 mg * 2 pills)
Behavioral:
cycle 2: fasted
for cycle 2 treatment: participants are asked to take the drug fasted
cycle 2: food
for cycle 2 treatment: participants are asked to take the drug after food intake
Drug:
cycle 3: treatment drug
for cycle 3 treatment: participants are given the oral treatment specification (60 mg *1 pill)
cycle 3: reference drug
for cycle 3 treatment: participants are given the oral reference specification (5 mg *2 pills + 25 mg * 2 pills)
Behavioral:
cycle 3: fasted
for cycle 3 treatment: participants are asked to take the drug fasted
cycle 3: food
for cycle 3 treatment: participants are asked to take the drug after food intake

Locations

Country Name City State
China First Affiliated Hospital Bengbu Medical College Bengbu Anhui

Sponsors (2)

Lead Sponsor Collaborator
Shenzhen TargetRx, Inc. First Affiliated Hospital Bengbu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Cmax Maximum concentration of TGRX-326 measured in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Primary Plasma AUC(0-t) Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Primary Plasma AUC(0-inf) Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary Plasma Tmax Time to maximum concentration of TGRX-326 measured in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary terminal elimination rate constant (lambda-z) terminal elimination rate constant calculated from plasma TGRX-326 concentrations During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary Elimination half-life (T1/2-Z) Time for TGRX-326 to decrease from maximum plasma concentration to half of maximum plasma concentration During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary AUC(%Extrap) Calculated percentage of Area under curve for AUC(0-inf) that is from last measurable timepoint ot infinity, calculated based on TGRX-326 plasma concentration over time curve. During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary Plasma volume of distribution (Vz/F) Apparent volume of distribution of TGRX-326 in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary Plasma clearance (CL/F) Apparent clearance of TGRX-326 in plasma During treatment period on Day 1 of each of three cycles (each cycle is one day, and there is a 10-day washout period between two cycles)
Secondary Adverse events/serious adverse events to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs) through completion of the study, a total duration of 37 days
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