Souseikai Fukuoka Mirai Hospital
Fukuoka, 813-0017, Japan
NCT Number: NCT05068466
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.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Fukuoka, 813-0017, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered Orally
Other names: Povorcitinib
Administered Orally
Time frame: 3 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: 17 Days
Maximum Observed Plasma Concentration of INCB054707
Time frame: 17 Days
Minimum Observed Plasma Concentration of INCB054707
Time frame: 17 Days
Time to reach maximum plasma concentration of INCB054707
Time frame: 17 Days
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Time frame: 17 Days
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Time frame: 17 Days
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 Apparent terminal phase disposition half-life of
Time frame: 17 Days
Oral dose clearance of INCB054707
Time frame: 17 Days
Apparent oral dose volume of distribution of INCB54707
Time frame: 17 Days
Average plasma concentration at steady state of INCB054707
Time frame: 17 Days
Apparent terminal-phase disposition rate constant of INCB054707
Incyte Biosciences Japan GK
Industry
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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