TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

NCT06304805 | Completed Phase 1

• 1 other identifier: TGRX-326-1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (6)

Group A

EXPERIMENTAL

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

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

Group B

EXPERIMENTAL

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

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

Group C

EXPERIMENTAL

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

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

Group D

EXPERIMENTAL

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

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

Group E

EXPERIMENTAL

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

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

Group F

EXPERIMENTAL

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

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

Interventions

cycle 1: treatment drug DRUG

for cycle 1 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

Group A; Group C; Group D; Group F

cycle 1: reference drug DRUG

for cycle 1 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

Group B; Group E

cycle 1: fasted BEHAVIORAL

for cycle 1 treatment: participants are asked to take the drug fasted

Group A; Group B; Group E; Group F

cycle 1: food BEHAVIORAL

for cycle 1 treatment: participants are asked to take the drug after food intake

Group C; Group D

cycle 2: treatment drug DRUG

for cycle 2 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

Group B; Group C; Group E; Group F

cycle 2: reference drug DRUG

for cycle 2 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

Group A; Group D

cycle 2: fasted BEHAVIORAL

for cycle 2 treatment: participants are asked to take the drug fasted

Group A; Group C; Group D; Group E

cycle 2: food BEHAVIORAL

for cycle 2 treatment: participants are asked to take the drug after food intake

Group B; Group F

cycle 3: treatment drug DRUG

for cycle 3 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

Group A; Group B; Group D; Group E

cycle 3: reference drug DRUG

for cycle 3 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

Group C; Group F

cycle 3: fasted BEHAVIORAL

for cycle 3 treatment: participants are asked to take the drug fasted

Group B; Group C; Group D; Group F

cycle 3: food BEHAVIORAL

for cycle 3 treatment: participants are asked to take the drug after food intake

Group A; Group E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huan Zhou, MD

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: December 13, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 19, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)