This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Floridian Clinical Research
Miami Lakes, Florida, United States
RECRUITINGOrlando Clinical Research Center
Orlando, Florida, United States
RECRUITINGPK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to approximately 3 months
PK for plasma INCB123667: AUCt
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: Up to approximately 3 months
PK for plasma INCB123667: AUC∞
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
Time frame: Up to approximately 3 months
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.
Time frame: Up to approximately 3.5 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.