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The purpose of this study is to determine whether ASC42 alters the pharmacokinetics of atorvastatin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin and ASC42 | Experimental | Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by Peak Plasma Concentration (Cmax) in the presence or absence of ASC42 | 120 hours | |
| Evaluate the pharmacokinetics (PK) of Atorvastatin and its two metabolites in the presence of ASC42 by Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf)) | 120 hours | |
| Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by time to peak plasma concentration (Tmax) in the presence or absence of ASC42 | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs) | Baseline to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ASC42 | Drug | Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin |
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |