Clinical trial · Interventional
TGRX-326 Pharmacokinetic Mass Balance
Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants
NCT06438367CI-TRIAL-00086277completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]TGRX-326 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: TGRX-326
- description
- healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension
- interventionNames
- Drug: [14C]TGRX-326
Primary outcomes (7)
- measure
- Urine radioactivity
- timeFrame
- Day-1 (day before dosing), Day 1 to Day 18 after dosing
- description
- \[C14\]TGRX-326 radioactivity detected in urine
- measure
- Fecal radioactivity
- timeFrame
- Day-1 (day before dosing), Day 1 to Day 18 after dosing
- description
- \[C14\]TGRX-326 radioactivity detected in feces
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.