Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUG[14C]TGRX-326
Healthy subjects will be given TGRX-326 60 mg orally on day 1.
Sponsors
The First Affiliated Hospital of Soochow University
Shenzhen TargetRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Urine %Dose | Day-1 (day before dosing), Day 1 to Day 18 after dosing | percentage of \[C14\]TGRX-326 radioactivity in urine |
| Fecal %Dose | Day-1 (day before dosing), Day 1 to Day 18 after dosing | percentage of \[C14\]TGRX-326 radioactivity in feces |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed