Non Small Cell Lung CancerPhase 1NCT06438367
TGRX-326 Pharmacokinetic Mass Balance
A Phase 1 study testing [14C]TGRX-326 in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.
Trial summary
This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- [14C]TGRX-326
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 21 Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males
- Age between 18 and 45 years old (both limits included)
- Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
- Willing to consent
- Able to communicate with investigator and complete study according to study protocol
Who cannot join
- Clinically significant results from comprehensive physical and clinical examinations
- Positive results on hepatitis, HIV or syphilis
- Clinically significant results from eye examination
- Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
- Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
- Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
Show all 23Show fewer
- Presence of any condition that could affect drug absorption
- Reception of major surgery within 6 months before screening, or surgical wounds not completely healed
- Presence of allergic reactions or may be allergic to ingredients in the investigational drug
- Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
- Habitual congestion or diarrhea
- Alcohol abuse or excessive alcohol consumption within 6 months before screening
- Excessive smoking within 3 months before screening
- Substance abuse or positive results on urine substance test
- Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
- History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies
- Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
- Participation in any other clinical studies within 3 months before screening
- Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
- Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
- Blood donation or blood loss of > 400 ml within 3 months before screening; blood donation or blood loss of > 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion
- Having special dietary requirements and unable to follow the uniform dietary plan in the study
- Any conditions that the investigator deemed unfit for the study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.
Read the detailed description
This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- [14C]TGRX-326
- 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.
[14C]TGRX-326Drug
Also called TGRX-326
Healthy subjects will be given TGRX-326 60 mg orally on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TGRX-326 | Experimental | healthy subjects will be given 60mg/100uCi[14C]TGRX-326 in suspension Receives: Drug: [14C]TGRX-326 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine radioactivity
[C14]TGRX-326 radioactivity detected in urine
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal radioactivity
[C14]TGRX-326 radioactivity detected in feces
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma AUC (Area under curve) percentage
percentage of [C14]TGRX-326 radioactivity in plasma
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Urine %Dose
percentage of [C14]TGRX-326 radioactivity in urine
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Fecal %Dose
percentage of [C14]TGRX-326 radioactivity in feces
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Cmax
Maximum concentration of [C14]TGRX-326 measured in plasma
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Plasma Tmax
Time to maximum concentration of [C14]TGRX-326 measured in plasma
Measured: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Secondary outcomes (1)
Adverse events/serious adverse events
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Measured: From screening through completion of study, an average of 1 to 1.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start26 Jun 2024
- Primary completion8 Jul 2024
- Study completion21 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, MD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438367
- Sponsor's protocol ID
- TGRX-326-1004
- Status last verified
- Feb 2025
- First submitted
- 27 May 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
- ClinicalTrials.gov ID
- NCT06438367
- Acronym / sponsor ID
- TGRX-326-1004
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.
Detailed description
This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: TGRX-326 | Experimental | Drug: [14C]TGRX-326healthy subjects will be given 60mg/100uCi[14C]TGRX-326 in suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males
- Age between 18 and 45 years old (both limits included)
- Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
- Willing to consent
- Able to communicate with investigator and complete study according to study protocol
Key exclusion criteria (23 listed)
- Clinically significant results from comprehensive physical and clinical examinations
- Positive results on hepatitis, HIV or syphilis
- Clinically significant results from eye examination
- Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
- Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]TGRX-326Also: TGRX-326Healthy subjects will be given TGRX-326 60 mg orally on day 1. | Drug | Experimental: TGRX-326 |
Primary outcome
Urine radioactivity
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
[C14]TGRX-326 radioactivity detected in urine
Fecal radioactivity
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
[C14]TGRX-326 radioactivity detected in feces
Plasma AUC (Area under curve) percentage
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in plasma
Urine %Dose
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in urine
Fecal %Dose
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
percentage of [C14]TGRX-326 radioactivity in feces
Plasma Cmax
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Maximum concentration of [C14]TGRX-326 measured in plasma
Plasma Tmax
Time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing
Time to maximum concentration of [C14]TGRX-326 measured in plasma
1 secondary outcome
Adverse events/serious adverse events
Time frame: From screening through completion of study, an average of 1 to 1.5 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liyan Miao, MD principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]TGRX-326 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 5 inclusion and 23 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 21 Feb 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?
Urine radioactivity (time frame: Day-1 (day before dosing), Day 1 to Day 18 after dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.