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In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of a high-fat meal on the rate and extent of absorption and exposure.
Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period, two-sequence, and crossover study in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed states in healthy subjects | Other | Fed states in healthy subjects |
|
| Fasted states in healthy subjects | Other | Fasted states in healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSK091 tablet | Drug | ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The PK parameters of Cmax | 9 days |
| AUC(0-tlast) | The PK parameters of AUC(0-tlast) | 9 days |
| AUC(0-∞) | The PK parameters of AUC(0-∞) | 9 days |
| Tmax | The PK parameters of Tmax | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Incidence and severity of treatment-emergent adverse events (TEAEs) | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Lu, PhD | Abbisko Therapeutics Co, Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | 114202 | Taiwan |
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| ID | Term |
|---|---|
| C572463 | AZD4547 |
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In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of high-fat meal on the rate and extent of absorption and exposure.
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