Clinical trial NCT06304805: TGRX-326 Pharmacokinetic Food Effect Bioavailability Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Shenzhen TargetRx, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Bengbu Medical University
First posted: 2024-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Cmax
timeFrame: 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)
measure: Plasma AUC(0-t)
timeFrame: 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)
measure: Plasma AUC(0-inf)
timeFrame: 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 outcomes:
measure: Plasma Tmax
timeFrame: 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)
measure: terminal elimination rate constant (lambda-z)
timeFrame: 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)
measure: Elimination half-life (T1/2-Z)
timeFrame: 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)
measure: AUC(%Extrap)
timeFrame: 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)
measure: Plasma volume of distribution (Vz/F)
timeFrame: 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)
measure: Plasma clearance (CL/F)
timeFrame: 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)
measure: Adverse events/serious adverse events
timeFrame: through completion of the study, a total duration of 37 days
Other outcomes:
Locations:
city: Bengbu
country: China
facility: First Affiliated Hospital Bengbu Medical College
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Bengbu Medical University
name: Huan Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: