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
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of [14C]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways;2.Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of fluorotinib maleate in healthy adult male participants;3.Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma.
Secondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma;2.Evaluate the safety and tolerability of [14C]Flonoltinib Maleate after a single oral administration in healthy adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flonoltinib | Experimental | 75mg/100 μCi[14C] Flonoltinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flonoltinib 75mg | Drug | Allocate 75mg /100 μCi[14C]flonoltinib once daily on an empty stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion rate of total radioactivity in urine and feces | Through 360 hours postdose | |
| Identify the main metabolites | Through 216 hours postdose | |
| Total radioactivity ratio in whole blood and plasma | Through 216 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Through 216 hours postdose | |
| Safety endpoint | Adverse events (AE) | From dosing (Day 0) through study completion (Day 16) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Fangmei | Contact | 13808086495 | fangmei.wang@zenitar.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tmax |
| Through 216 hours postdose |
| AUC0-t | Through 216 hours postdose |
| t1/2 | Through 216 hours postdose |