Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: TGRX-326 | Experimental | healthy subjects will be given 60mg/100uCi[14C]TGRX-326 in suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]TGRX-326 | Drug | Healthy subjects will be given TGRX-326 60 mg orally on day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine radioactivity | [C14]TGRX-326 radioactivity detected in urine | Day-1 (day before dosing), Day 1 to Day 18 after dosing |
| Fecal radioactivity | [C14]TGRX-326 radioactivity detected in feces | 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 | Day-1 (day before dosing), Day 1 to Day 18 after dosing |
| Urine %Dose | percentage of [C14]TGRX-326 radioactivity in urine | Day-1 (day before dosing), Day 1 to Day 18 after dosing |
| Fecal %Dose | percentage of [C14]TGRX-326 radioactivity in feces | Day-1 (day before dosing), Day 1 to Day 18 after dosing |
| Plasma Cmax | Maximum concentration of [C14]TGRX-326 measured in plasma | 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 | Day-1 (day before dosing), Day 1 to Day 18 after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events/serious adverse events | to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs) | From screening through completion of study, an average of 1 to 1.5 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |