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The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Three period alternative intervention and fed/fasted sequence |
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| Sequence B | Experimental | Three period alternative intervention and fed/fasted sequence |
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| Sequence C | Experimental | Three period alternative intervention and fed/fasted sequence |
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| Sequence D | Experimental | Three period alternative intervention and fed/fasted sequence |
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| Sequence E | Experimental | Three period alternative intervention and fed/fasted sequence |
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| Sequence F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-001 | Drug | K-877-ER and CSG452 combination tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax of K-877 and CSG452 | Maximum observed plasma concentration (Cmax) of K-877 and CSG452 | 1 hour before dosing and at multiple time points (up to 48 hours) post dose |
| AUC0-t of K-877 and CSG452 | Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) | 1 hour before dosing and at multiple time points (up to 48 hours) post dose |
| AUC0-inf of K-877-and CSG452 | Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf). | 1 hour before dosing and at multiple time points (up to 48 hours) post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD - Austin Research Unit | Austin | Texas | 78744 | United States |
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Randomized, open-label, six-sequence, three-period, crossover study
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Three period alternative intervention and fed/fasted sequence |
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| K-877-ER | Drug | K-877-ER tablet |
|
| CSG452 | Drug | CSG452 tablet |
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| ID | Term |
|---|---|
| C575086 | 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol |
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