TGRX-326 Pharmacokinetic Mass Balance
- Registration Number
- NCT06438367
- Lead Sponsor
- Shenzhen TargetRx, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: TGRX-326 [14C]TGRX-326 healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension
- Primary Outcome Measures
Name Time Method Urine radioactivity Day-1 (day before dosing), Day 1 to Day 18 after dosing \[C14\]TGRX-326 radioactivity detected in urine
Fecal radioactivity Day-1 (day before dosing), Day 1 to Day 18 after dosing \[C14\]TGRX-326 radioactivity detected in feces
Urine %Dose Day-1 (day before dosing), Day 1 to Day 18 after dosing percentage of \[C14\]TGRX-326 radioactivity in urine
Plasma AUC (Area under curve) percentage Day-1 (day before dosing), Day 1 to Day 18 after dosing percentage of \[C14\]TGRX-326 radioactivity in plasma
Fecal %Dose Day-1 (day before dosing), Day 1 to Day 18 after dosing percentage of \[C14\]TGRX-326 radioactivity in feces
Plasma Cmax Day-1 (day before dosing), Day 1 to Day 18 after dosing Maximum concentration of \[C14\]TGRX-326 measured in plasma
Plasma Tmax Day-1 (day before dosing), Day 1 to Day 18 after dosing Time to maximum concentration of \[C14\]TGRX-326 measured in plasma
- Secondary Outcome Measures
Name Time Method Adverse events/serious adverse events From screening through completion of study, an average of 1 to 1.5 months. to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China