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To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASK120067 in fast condition | Experimental | Take ASK120067 tablets orally once in the first day at 160mg in fast condition. |
|
| ASK120067 in fed condition | Experimental | Take ASK120067 tablets orally once in the first day at 160mg in fed condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASK120067 | Drug | Take ASK120067 tablets orally in first day at 160 mg in fast condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out maximum concentration | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| AUC | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out area under the plasma concentration-time curve | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out time to reach maximum concentration | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zourong Ruan | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ASK120067 in fed condition | Dietary Supplement | Take ASK120067 tablets orally in first day at 160 mg in fed condition. |
|
| t1/2 | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent end elimination half-life | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| CL/F | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent clearance | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| Vd/F | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent volume of distribution | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| λz | Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out apparent terminal elimination rate constant | Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose) |
| Incidence and Severity of Treatment-Emergent Adverse Events | Assessed by number and severity of adverse events as recorded on the case report form. | Adverse events will be collected from baseline until 12 days after the administration and the follow-up period |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |