NCT06438367CompletedPhase 1
TGRX-326 Pharmacokinetic Mass Balance
Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 27 May 2024
- Start date
- 26 Jun 2024
- Primary completion date
- 8 Jul 2024
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06438367
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 26 Jun 2024 to the primary completion date, 8 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Alcohol abuse or excessive alcohol consumption within 6 months before screening
- Excessive smoking within 3 months before screening
- 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
- 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
Other illness
- Positive results on hepatitis, HIV or syphilis
- Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
- Presence of any condition that could affect drug absorption
- Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
- 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
- Any conditions that the investigator deemed unfit for the study
Other
- Clinically significant results from comprehensive physical and clinical examinations
- Clinically significant results from eye examination
- Habitual congestion or diarrhea
- Substance abuse or positive results on urine substance test
- Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
- 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
- Having special dietary requirements and unable to follow the uniform dietary plan in the study
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.