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Non Small Cell Lung CancerPhase 1NCT06304805

TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

A Phase 1 study testing cycle 1: treatment drug, cycle 1: reference drug and cycle 1: fasted in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
cycle 1: treatment drug, cycle 1: reference drug and cycle 1: fasted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
13 Dec 2023to 19 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital Bengbu Medical College

    Bengbu, Anhui, 233004

Other trials in China

About this 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

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

Read the 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.

Being tested
cycle 1: treatment drug, cycle 1: reference drug, cycle 1: fasted, cycle 1: food, cycle 2: treatment drug
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cycle 1: treatment drugDrug

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

  • cycle 1: reference drugDrug

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

  • cycle 1: fastedBehavioural

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

  • cycle 1: foodBehavioural

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

  • cycle 2: treatment drugDrug

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

  • cycle 2: reference drugDrug

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

  • cycle 2: fastedBehavioural

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

  • cycle 2: foodBehavioural

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

  • cycle 3: treatment drugDrug

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

  • cycle 3: reference drugDrug

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

  • cycle 3: fastedBehavioural

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

  • cycle 3: foodBehavioural

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

Study groups in NCT06304805
Study groupRoleWhat they receive
Group AExperimentalcycle 1: treatment drug + fasted cycle 2: reference drug + fasted cycle 3: treatment drug + food
Receives: 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 BExperimentalcycle 1: reference drug + fasted cycle 2: treatment drug + food cycle 3: treatment drug + fasted
Receives: 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 CExperimentalcycle 1: treatment drug + food cycle 2: treatment drug + fasted cycle 3: reference drug + fasted
Receives: 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 DExperimentalcycle 1: treatment drug + food cycle 2: reference drug + fasted cycle 3: treatment drug + fasted
Receives: 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 EExperimentalcycle 1: reference drug + fasted cycle 2: treatment drug + fasted cycle 3: treatment drug + food
Receives: 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 FExperimentalcycle 1: treatment drug + fasted cycle 2: treatment drug + food cycle 3: reference drug + fasted
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Cmax

    Maximum concentration of TGRX-326 measured in plasma

    Measured: 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)

  2. 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

    Measured: 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)

  3. Plasma AUC(0-inf)

    Area Under drug concentration-time curve from time 0 to infinity for TGRX-326 as measured in plasma

    Measured: 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)

  1. Plasma Tmax

    Time to maximum concentration of TGRX-326 measured in plasma

    Measured: 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)

  2. terminal elimination rate constant (lambda-z)

    terminal elimination rate constant calculated from plasma TGRX-326 concentrations

    Measured: 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)

  3. Elimination half-life (T1/2-Z)

    Time for TGRX-326 to decrease from maximum plasma concentration to half of maximum plasma concentration

    Measured: 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)

  4. 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.

    Measured: 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)

  5. Plasma volume of distribution (Vz/F)

    Apparent volume of distribution of TGRX-326 in plasma

    Measured: 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)

  6. Plasma clearance (CL/F)

    Apparent clearance of TGRX-326 in plasma

    Measured: 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)

  7. Adverse events/serious adverse events

    to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

    Measured: through completion of the study, a total duration of 37 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start13 Dec 2023
  3. Primary completion12 Jan 2024
  4. Study completion19 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304805
Sponsor's protocol ID
TGRX-326-1002
Status last verified
May 2025
First submitted
5 Mar 2024
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cycle 1: treatment drug, cycle 1: reference drug and cycle 1: fasted in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Cmax (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06304805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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