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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] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.
Participants will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical trial unit 2 days before the dose (D-2). Participants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning.
Urine and stool samples will be collected from participants before and at specified intervals between 0 and 192 hours after taking the drug and blood samples will be collected at specified time points between 0 and 120 hours before and after taking the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]ABSK011 | Experimental | Participants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]ABSK011 | Drug | The standard meal was taken the night before administration, and the patient was fasted for at least 10 h without drinking water overnight. The next morning, eat a low-fat meal, finish the meal within 30 minutes, and take the test drug with warm water 30 minutes (±5 minutes) after the beginning of the meal. The total volume of warm water and suspension liquid is about 240 mL. Except for meals and administration, no water was allowed 1 hour before and 1 hour after medication. No food is allowed for 4 hours after taking the medication. Throughout the study, participants received meals provided by the center 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 ABSK011 and its metabolites after single oral administration of [14C]ABSK011 in healthy adult male subjects | All excreted urine and feces samples at specified time points during 0-192 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 ABSK011 after single oral administration of [14C] ABSK011 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-192 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 | To evaluate the pharmacokinetics of ABSK011 and its major metabolites in the urine of healthy adult male subjects after a single oral administration [14C] of ABSK011. | Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol |
| 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 [14C] ABSK011 in healthy adult male subjects | From signing the ICF until 9 days after the first dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan LU, Doctor | Contact | 13700000000 | clinical@abbisko.cn |
| Name | Affiliation | Role |
|---|---|---|
| Quankun Zhuang, Doctor | Beijing GoBroad Hospital | Principal Investigator |
| Xuemei Liu, Doctor | Beijing GoBroad Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 102206 | China |
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