TGRX-326 Pharmacokinetic Food Effect Bioavailability Study
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT06304805
- Lead Sponsor
- Shenzhen TargetRx, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Plasma AUC(0-inf) 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) Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma
Plasma AUC(0-t) 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) Area Under drug concentration-time curve (AUC) from time 0 to last measureable timepoint for TGRX-326 as measured in plasma
Plasma Cmax 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) Maximum concentration of TGRX-326 measured in plasma
- Secondary Outcome Measures
Name Time Method Plasma Tmax 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) Time to maximum concentration of TGRX-326 measured in plasma
Plasma clearance (CL/F) 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) Apparent clearance of TGRX-326 in plasma
AUC(%Extrap) 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) 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.
Plasma volume of distribution (Vz/F) 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) Apparent volume of distribution of TGRX-326 in plasma
terminal elimination rate constant (lambda-z) 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) terminal elimination rate constant calculated from plasma TGRX-326 concentrations
Elimination half-life (T1/2-Z) 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) Time for TGRX-326 to decrease from maximum plasma concentration to half of maximum plasma concentration
Adverse events/serious adverse events through completion of the study, a total duration of 37 days to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Trial Locations
- Locations (1)
First Affiliated Hospital Bengbu Medical College
🇨🇳Bengbu, Anhui, China