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This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects. The study plans to enroll 6 to 10 healthy male subjects to ensure at least 6 evaluable subjects.
Subjects will be screened within 14 days before dose administration (D-14 to D-3), and will be admitted to the trial ward two days before dose administration (D-2).
On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.
All excreted urine and feces samples and blood samples at specified time points during 0-504 hours after dosing will be collected. Random feces within 48 hours prior to dosing and random urine within 24 hours prior to dosing will be collected as blank samples (if there are multiple blank samples, the most recent blank sample before dosing will be selected for analysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]ABSK021 Suspension | Experimental | On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimicotinib(ABSK021) | Drug | A standard meal should be given to the subjects in the evening before dosing. Then, the subjects should fast for at least 10 hours. Water is not prohibited overnight. The next morning, the subjects should administer study drug in fasted state with warm water. The total volume of warm water and suspension is approximately 240 mL. Water is prohibited from 1 hour before dosing to 1 hour after dosing. No food is allowed within 4 hours after dosing. During the study, subjects will receive standardized meals at approximately the same time each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) | To assess the routes and rates of elimination of ABSK021 and its metabolites after single oral administration of [14C]ABSK021 in healthy adult male subjects | All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected. |
| Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC); | To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected. | Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol |
| Identification of major metabolites in plasma, urine, and fecal samples | To determine the metabolism and elimination pathways of ABSK021 after single oral administration of [14C] ABSK021 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces and plasma samples at specified time points during 0-504 hours after dosing will be collected. | Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol |
| AUC 0-∞ | To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the urine of healthy adult male subjects after a single oral administration [14C] of ABSK021. | Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol |
| Tmax |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc. | To assess the safety and tolerability of a single oral dose of approximately 50 mg with approximately 100 μCi [14C] ABSK021 in healthy adult male subjects | From signing the ICF until 22 days after the first dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, Professor | 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 | 215000 | China |
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On Day 1, subjects will receive a single oral dose of approximately 50 mg ABSK021 containing approximately 100 μCi of [14C] ABSK021 in the fasted state.
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To evaluate the pharmacokinetics of ABSK021 and its major metabolites in the fecal of healthy adult male subjects after a single oral administration [14C] of ABSK021 |
| Conduct testing within 1 month after all subjects collect PK samples at all time points required by the protocol |