This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Administered Orally
Administered Orally
Souseikai Fukuoka Mirai Hospital
Fukuoka, Japan
Number of participants with Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: 3 months
Pharmacokinetics Parameter : Cmax of INCB054707
Maximum Observed Plasma Concentration of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : Cmin of INCB054707
Minimum Observed Plasma Concentration of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : tmax of INCB054707
Time to reach maximum plasma concentration of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : AUC(0-t) of INCB054707
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : AUC(0-∞) of INCB054707
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : AUC(0-tau) of INCB054707
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : t1/2 of INCB054707
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Pharmacokinetics Parameter : t1/2 of Apparent terminal phase disposition half-life of
Time frame: 17 Days
Pharmacokinetics Parameter : CL/F of INCB054707
Oral dose clearance of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : Vz/F of INCB054707
Apparent oral dose volume of distribution of INCB54707
Time frame: 17 Days
Pharmacokinetics Parameter : Cavg of INCB054707
Average plasma concentration at steady state of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : λz of INCB054707
Apparent terminal-phase disposition rate constant of INCB054707
Time frame: 17 Days