This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
INCB054707 75 mg will be administered orally on Day 1.
Orange County Research Center
Tustin, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
San Antonio, Texas, United States
Apex Gmbh
Munich, Germany
Pharmacokinetics Parameter: Cmax of INCBC054707
Defined as maximum observed plasma concentration of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.
Time frame: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Defined as area under the concentration-time curve From 0 to Infinity of INCB054707
Time frame: Days 1 - 5
Number of 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: up to 15 days
Pharmacokinetics Parameter: tmax of INCB054707
Defined as time to reach maximum plasma concentration of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: t1/2 0f INCB054707
Defined as apparent terminal phase disposition half-life of INCB54707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: CL/F of INCB054707
Defined as oral dose clearance of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter:: Vz/F of INCB054707
Defined as apparent oral dose volume of distribution of INCB054707
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Time frame: Days 1 - 5