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The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg Dose | Experimental | Single dose of 25 mg ASN002 |
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| 50 mg Dose | Experimental | Single dose of 50 mg ASN002 |
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| 100 mg Food effect cross over | Experimental | 100 mg single dose under both fasted and fed conditions in a cross over fashion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN002 | Drug | Single dose study with food effect |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting adverse events during the study | Safety and tolerability will be determined by the number of subjects reporting adverse events during the study. | Days 1-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours. | Days 1-6 |
| Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions |
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Inclusion Criteria:
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| David Wyatt, MD | InVentiv Health Clinical Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InVentiv Health | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| C000707471 | gusacitinib |
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Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours. |
| Days 1-6 |
| Maximum Plasma Concentration of ASN002 | Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state. | Days 1-6 |
| Maximum Plasma Concentration of ASN002 under fed and fasted conditions | Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state. | Days 1-6 |
| Drug half life of ASN002 | Calculate terminal elimination rate constant and terminal half-life of ASN002 | Days 1-6 |
| Drug half life of ASN002 under fed and fasted conditions | Calculate terminal elimination rate constant and terminal half-life of ASN002 | Days 1-6 |