TGRX-326 Phase I/II Pharmacokinetic Study

Shenzhen TargetRx

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: cycle 1: reference drug; Behavioral: cycle 1: fasted; Behavioral: cycle 1: food; Drug: cycle 3: reference drug; Drug: cycle 2: treatment drug; Behavioral: cycle 3: food; Behavioral: cycle 3: fasted; Drug: cycle 1: treatment drug; Drug: cycle 2: reference drug; Behavioral: cycle 2: food; Drug: cycle 3: treatment drug; Behavioral: cycle 2: fasted

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06304805

TGRX-326-1002

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 6 patient groups

Group A

Experimental group

Description:

cycle 1: treatment drug + fasted cycle 2: reference drug + fasted cycle 3: treatment drug + food

Treatment:

Behavioral: cycle 2: fasted

Behavioral: cycle 3: food

Drug: cycle 3: treatment drug

Drug: cycle 2: reference drug

Behavioral: cycle 1: fasted

Drug: cycle 1: treatment drug

Group B

Experimental group

Description:

cycle 1: reference drug + fasted cycle 2: treatment drug + food cycle 3: treatment drug + fasted

Treatment:

Behavioral: cycle 3: fasted

Drug: cycle 3: treatment drug

Drug: cycle 2: treatment drug

Behavioral: cycle 2: food

Behavioral: cycle 1: fasted

Drug: cycle 1: reference drug

Group C

Experimental group

Description:

cycle 1: treatment drug + food cycle 2: treatment drug + fasted cycle 3: reference drug + fasted

Treatment:

Behavioral: cycle 3: fasted

Behavioral: cycle 2: fasted

Drug: cycle 2: treatment drug

Drug: cycle 3: reference drug

Behavioral: cycle 1: food

Drug: cycle 1: treatment drug

Group D

Experimental group

Description:

cycle 1: treatment drug + food cycle 2: reference drug + fasted cycle 3: treatment drug + fasted

Treatment:

Behavioral: cycle 3: fasted

Behavioral: cycle 2: fasted

Drug: cycle 3: treatment drug

Drug: cycle 2: reference drug

Behavioral: cycle 1: food

Drug: cycle 1: treatment drug

Group E

Experimental group

Description:

cycle 1: reference drug + fasted cycle 2: treatment drug + fasted cycle 3: treatment drug + food

Treatment:

Behavioral: cycle 2: fasted

Behavioral: cycle 3: food

Drug: cycle 3: treatment drug

Drug: cycle 2: treatment drug

Behavioral: cycle 1: fasted

Drug: cycle 1: reference drug

Group F

Experimental group

Description:

cycle 1: treatment drug + fasted cycle 2: treatment drug + food cycle 3: reference drug + fasted

Treatment:

Behavioral: cycle 3: fasted

Drug: cycle 2: treatment drug

Behavioral: cycle 2: food

Drug: cycle 3: reference drug

Behavioral: cycle 1: fasted

Drug: cycle 1: treatment drug