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This study is a single center, open lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of ABSK021 Oral administration. It is planned to enroll 32 healthy subjects and assign them to two parallel test groups, Part A (ABSK021 combined with Itraconazole) and Part B (ABSK021 combined with Rifampicin).
Each study section includes a screening period conducted within 28 days prior to the first administration of the investigational drug, a trial period of 2 cycles, and withdrawal visits on the 21st or 14th day (Part A) or 14th day (Part B) after the last dose of ABSK021. This study will end after all participants complete 2 cycles of the trial period and withdraw from the study visit.
Whether subjects who have completed the first cycle of the study will enter the second cycle of the study will be determined by the researcher based on their physical condition and relevant visit examination results. For the subjects who interrupted or permanently suspended the study due to adverse events or clinically significant laboratory Outlier, the interview rate shall be determined according to the requirements of the research institution or the clinical indication syndrome until the AE is resolved or stabilized, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSK201 and Itraconazole/Rifampicin | Experimental | Part A: Subjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4. Part B: Subjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part A ABSK201 and Itraconazole | Drug | Subjects will receive a single 10mg Oral administration of ABSK021 at C1D1, followed by a washout period of at least 14 days. The second cycle (C2): after the end of the first cycle, the subjects will receive 200 mg of C2D1-C2D24 Itraconazole oral liquid and a single 10 mg of ABSK021 Oral administration at C2D4. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Peak Plasma Concentration (Cmax) | Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2. | Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol |
| Part A_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration of ABSK021 capsules and combination of itraconazole oral solution using Area under the plasma concentration versus time curve (AUC) | Collect plasma samples of ABSK021 and its metabolites (if data allows), as well as itraconazole and its metabolite hydroxyitraconazole, from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are collected at C1 and C2, while plasma samples of itraconazole and its metabolite hydroxyitraconazole are collected at C2. | Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol |
| Part B_(1)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Peak Plasma Concentration (Cmax). | Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2. | Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol |
| Part B_(2)Pharmacokinetic Outcome Measures of ABSK021 after single oral administration and in combination with Rifampicin using Area under the plasma concentration versus time curve (AUC). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang, Professor | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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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| Part A ABSK201 and Rifampicin | Drug | Subjects will receive a single dose of 50 mg of ABSK021 Oral administration once at C1D1, followed by a washout period of at least 14 days. Subjects will receive 600 mg of Rifampicin capsules once a day at C2D1-C2D15 and a single dose of ABSK021 Oral administration at C2D7, with the dose of 50 mg. |
|
Collect plasma samples of ABSK021 and its metabolites (if data allows) and rifampicin from all subjects before and after administration for PK evaluation. Plasma samples of ABSK021 and its metabolites (if data allows) are sampled at C1 and C2, while rifampicin plasma samples are sampled at C2. |
| Conduct testing within 1 month after all volunteers collect PK samples at all time points required by the protocol |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |