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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
30
PPD - Austin Research Unit
Austin, Texas, United States
Cmax of K-877 and CSG452
Maximum observed plasma concentration (Cmax) of K-877 and CSG452
Time frame: 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)
Time frame: 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).
Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
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