The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Tablet
Celerion, Inc
Tempe, Arizona, United States
Pharmacokinetics Parameter (PK): Cmax of INCB057643
Defined as maximum observed plasma concentration of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: AUC(0-last) of INCB057643
Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: AUC 0-∞ of INCB057643
Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.
Time frame: Up to Day 10
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to Day 26
Pharmacokinetics Parameter: Tmax of INCB057643
Defined as the time to reach the maximum plasma concentration of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: t1/2 of INCB057643
Defined as the apparent terminal phase disposition half-life of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: CL/F INCB057643
Defined as the apparent oral dose clearance of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: V2/F of INCB057643
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Defined as the apparent oral dose volume of distribution of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: λz of INCB057643
Defined as apparent terminal-phase disposition rate constant of INCB057643.
Time frame: Up to Day 10
Pharmacokinetics Parameter: %AUCexp of INCB057643
Defined as percentage of AUC0-∞ due to extrapolation from the time of last quantifiable concentration to infinity of INCB057643.
Time frame: Up to Day 10