CompletedPhase 1

TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

China24 participantsStarted 2023-12-13

Plain-language 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

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 investi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

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)

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)

Trial details

NCT IDNCT06304805

SponsorShenzhen TargetRx Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-12

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)

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)